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FDA 510(k)

POWERED MUSCLE STIMULATOR

K-Number: K821511 · 1982-08-16

ApplicantHigh Country Ent.
Decision Date1982-08-16
Product CodeEPF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

POWERED MUSCLE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is High Country Ent.. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K821511. The device is classified under product code EPF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERED MUSCLE STIMULATOR?

POWERED MUSCLE STIMULATOR is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is High Country Ent.. The 510(k) number is K821511.

When did POWERED MUSCLE STIMULATOR receive FDA 510(k) clearance?

POWERED MUSCLE STIMULATOR received FDA 510(k) clearance on 1982-08-16, under 510(k) number K821511.

Who is the listed applicant for POWERED MUSCLE STIMULATOR?

The FDA 510(k) record lists High Country Ent. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWERED MUSCLE STIMULATOR?

The FDA product code for POWERED MUSCLE STIMULATOR is EPF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 30799667Powered muscle stimulators: an investigation into newly FDA 510(k) approved devices marketed for muscle toning and esthetic benefit.The Journal of dermatological treatment ()

Related Devices (Code: EPF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K982683TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONTelex Communications, Inc.K974658INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, ITPhonic Ear, Inc.K974287FM RECEIVER - AUDITORY TRAINERPhonic Ear, Inc.K970687WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK970665WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK960567HF MEGA EARMaxi-Aids, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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