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FDA 510(k)

TENS MAX

K-Number: K823388 · 1983-01-08

ApplicantFujisawa Electronics Co.
Decision Date1983-01-08
Product CodeGFK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TENS MAX is the device name listed in this FDA 510(k) record. The listed applicant is Fujisawa Electronics Co.. It received FDA 510(k) clearance on 1983-01-08 under 510(k) number K823388. The device is classified under product code GFK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENS MAX?

TENS MAX is a medical device that received FDA 510(k) clearance on 1983-01-08. The listed applicant is Fujisawa Electronics Co.. The 510(k) number is K823388.

When did TENS MAX receive FDA 510(k) clearance?

TENS MAX received FDA 510(k) clearance on 1983-01-08, under 510(k) number K823388.

Who is the listed applicant for TENS MAX?

The FDA 510(k) record lists Fujisawa Electronics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS MAX?

The FDA product code for TENS MAX is GFK.

Official Source

View on FDA Database →

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

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