Guidance Document for Powered Muscle Stimulator 510(k)s - Guidance for Industry, FDA Reviewers/Staff and Compliance

Name: Guidance Document for Powered Muscle Stimulator 510(k)s - Guidance for Industry, FDA Reviewers/Staff and Compliance
Creator: Food and Drug Administration
Keywords: 510k,compliance,fda,guidances,industry,muscle,pre-market,review,stimulators

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

June 8, 1999

Last updated

February 15, 2023

Description

A guidance document providing instructions for the premarket review of Powered Muscle Stimulator 510(k)s by the FDA and industry staff.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Guidance Document for Powered Muscle Stimulator 510(k)s - Guidance for Industry, FDA Reviewers/Staff and Compliance

Updated on February 15, 2023

pdf (54.7KB)

URL: https://www.fda.gov/media/71804/download
Permalink: https://data.openrid.co/en/datasets/r/4f43ac19-d3a1-4c21-8ad2-7b66adc84ccb
MIME Type: application/pdf

Created on: June 8, 1999
Modified on: February 15, 2023

Size: 54.7KB

Guidance Document for Powered Muscle Stimulator 510(k)s - Guidance for Industry, FDA Reviewers/Staff and Compliance

Information

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Regulated products

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Published

Last updated

Description

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Country / Region

License

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