21 CFR Chapter I Subchapter H – Medical Devices – Part 890 Physical Medicine Devices From Food and Drug Administration (FDA) 🇺🇸 Regulation on physical medicine devices under 21 CFR Chapter I Subchapter H - Medical Devices - Part 890. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-19722. The Food and Drug Administration (FDA or we) is classifying the external compression device for internal jugular vein compression into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Physical Medicine Devices; Classification of the Virtual Reality Behavioral Therapy Device for Pain Relief From Food and Drug Administration (FDA) 🇺🇸 Document number 2023-00014. The Food and Drug Administration (FDA, Agency, or we) is classifying the virtual reality behavioral therapy device for pain relief into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 6, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Physical Medicine Devices; Classification of the Electroencephalography-Driven Upper Extremity Powered Exerciser From Food and Drug Administration (FDA) 🇺🇸 Document number 2023-00007. The Food and Drug Administration (FDA, Agency, or we) is classifying the electroencephalography (EEG)-driven upper extremity powered exerciser into class II (special controls). The special controls that apply to the device type are identified in this order and will be… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 6, 2023 Other (Public Domain) 0 reuses 0 favorites
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-17543. The Food and Drug Administration (FDA) is proposing to reclassify non-invasive bone growth stimulators, postamendments class III devices (product codes LOF and LPQ), into class II (special controls), subject to premarket notification. FDA is also proposing a new device… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Physical Medicine Therapeutic Devices; Classification of the Internal Therapeutic Massager From Food and Drug Administration (FDA) 🇺🇸 Document number 2019-23304. The Food and Drug Administration (FDA or we) is classifying the internal therapeutic massager into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the internal… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 25, 2019 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-25001. The Food and Drug Administration (FDA) is classifying the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components into class… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 18, 2016 Other (Public Domain) 0 reuses 0 favorites
Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-17609. The Food and Drug Administration (FDA) is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments class III devices (regulated under product code EGJ), into class II (special controls) and to amend the device… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 26, 2016 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Exemption From Premarket Notification; Class II Devices; Electric Positioning Chair From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-29633. The Food and Drug Administration (FDA or the Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for electric positioning chair devices. An electric positioning chair is a device with a motorized positioning… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on November 20, 2015 Other (Public Domain) 0 reuses 0 favorites
Physical Medicine Devices; Reclassification of Shortwave Diathermy for All Other Uses, Henceforth To Be Known as Nonthermal Shortwave Therapy From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-25923. The Food and Drug Administration (FDA) is issuing a final order to reclassify shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device "nonthermal shortwave therapy" (SWT). FDA is also… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 13, 2015 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton; Republication From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-10332. The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled "Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton" that published in the Federal Register on February 24,… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 4, 2015 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Physical Medicine Devices; Classification of the Powered Exoskeleton From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-03692. The Food and Drug Administration (FDA) is classifying the powered exoskeleton into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the powered exoskeleton's… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 24, 2015 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Physical Medicine Devices; Classification of the Nonpowered Lower Extremity Pressure Wrap From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-15626. The Food and Drug Administration (FDA) is classifying the nonpowered lower extremity pressure wrap into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 3, 2014 Other (Public Domain) 0 reuses 0 favorites
Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-08257. The Food and Drug Administration (FDA) is issuing a final order to reclassify stair-climbing wheelchairs, a class III device, into class II (special controls) based on new information and subject to premarket notification, and further clarify the identification. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 14, 2014 Other (Public Domain) 0 reuses 0 favorites
Physical Medicine Devices; Reclassification and Renaming of Shortwave Diathermy for All Other Uses From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-03594. The Food and Drug Administration (FDA) is proposing to reclassify the shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device "nonthermal shortwave therapy (SWT)." FDA is proposing this… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 20, 2014 Other (Public Domain) 0 reuses 0 favorites
Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-13864. The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify stair-climbing wheelchairs, a class III device, into class II (special controls) based on new information and subject to premarket notification, and to further clarify the… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 12, 2013 Other (Public Domain) 0 reuses 0 favorites
Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II Devices and Exemption From Premarket Notification From Food and Drug Administration (FDA) 🇺🇸 Document number 2010-7637. The Food and Drug Administration (FDA) is proposing to amend certain neurological device and physical medicine device regulations to establish special controls for these class II devices and to exempt some of these devices from the premarket notification requirements of… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 5, 2010 Other (Public Domain) 0 reuses 0 favorites
Physical Medicine Devices; Revision of the Identification of the Ionotophoresis Device From Food and Drug Administration (FDA) 🇺🇸 Document number 00-21251. The Food and Drug Administration (FDA) is proposing to amend the physical medicine devices regulations to remove the class III (premarket approval) iontophoresis device identification. FDA is taking this action because the agency believes that there were no preamendments… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 22, 2000 Other (Public Domain) 0 reuses 0 favorites
Cardiovascular, Orthopedic, and Physical Medicine Diagnostic Devices; Reclassification of Cardiopulmonary Bypass Accessory Equipment, Goniometer Device, and Electrode Cable Devices From Food and Drug Administration (FDA) 🇺🇸 Document number 00-8850. The Food and Drug Administration (FDA) is reclassifying from class I into class II the cardiopulmonary bypass accessory equipment device that involves an electrical connection to the patient, the goniometer device, and the electrode cable. FDA is also exempting these… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 11, 2000 Other (Public Domain) 0 reuses 0 favorites