FDA 510(k)

POWERSTIM ELECTRONIC MUSCLE STIMULATOR

K-Number: K861399 · 1986-06-17

Decision Date1986-06-17

Product Code

DecisionSubstantially Equivalent

Device Summary

POWERSTIM ELECTRONIC MUSCLE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med Systems Corp.. It received FDA 510(k) clearance on 1986-06-17 under 510(k) number K861399. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERSTIM ELECTRONIC MUSCLE STIMULATOR?

POWERSTIM ELECTRONIC MUSCLE STIMULATOR is a medical device that received FDA 510(k) clearance on 1986-06-17. The listed applicant is Bio-Med Systems Corp.. The 510(k) number is K861399.

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

POWERSTIM ELECTRONIC MUSCLE STIMULATOR received FDA 510(k) clearance on 1986-06-17, under 510(k) number K861399.

Who is the listed applicant for POWERSTIM ELECTRONIC MUSCLE STIMULATOR?

The FDA 510(k) record lists Bio-Med Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

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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.