FDA 510(k)

EASY TENS

K-Number: K881704 · 1988-05-04

Decision Date1988-05-04

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EASY TENS is the device name listed in this FDA 510(k) record. The listed applicant is American Imex. It received FDA 510(k) clearance on 1988-05-04 under 510(k) number K881704. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASY TENS?

EASY TENS is a medical device that received FDA 510(k) clearance on 1988-05-04. The listed applicant is American Imex. The 510(k) number is K881704.

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

EASY TENS received FDA 510(k) clearance on 1988-05-04, under 510(k) number K881704.

Who is the listed applicant for EASY TENS?

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

What is the FDA product code for EASY TENS?

The FDA product code for EASY TENS is GZJ.

Other records listing American Imex as applicant

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.

K032003PREMIER PLUS K982221PREMIER AP K926326MICROCARE(TM)K912289ULTIMA XS, MODIFICATION K895295ULTIMA XS MICROCURRENT TENS K894388ZIMMER TENS

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Related Devices (Code: GZJ)

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimed K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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.