FDA 510(k)

TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)

K-Number: K874469 · 1988-01-28

Decision Date1988-01-28

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) is the device name listed in this FDA 510(k) record. The listed applicant is Axelgaard Mfg. Co., Ltd.. It received FDA 510(k) clearance on 1988-01-28 under 510(k) number K874469. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)?

TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) is a medical device that received FDA 510(k) clearance on 1988-01-28. The listed applicant is Axelgaard Mfg. Co., Ltd.. The 510(k) number is K874469.

When did TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) receive FDA 510(k) clearance?

TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) received FDA 510(k) clearance on 1988-01-28, under 510(k) number K874469.

Who is the listed applicant for TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)?

The FDA 510(k) record lists Axelgaard Mfg. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)?

The FDA product code for TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) is GXY.

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Official Source

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