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FDA 510(k)

A TENS (MODEL AI-86)

K-Number: K861709 · 1986-05-16

ApplicantAmerican Imex
Decision Date1986-05-16
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

A TENS (MODEL AI-86) is the device name listed in this FDA 510(k) record. The listed applicant is American Imex. It received FDA 510(k) clearance on 1986-05-16 under 510(k) number K861709. 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 A TENS (MODEL AI-86)?

A TENS (MODEL AI-86) is a medical device that received FDA 510(k) clearance on 1986-05-16. The listed applicant is American Imex. The 510(k) number is K861709.

When did A TENS (MODEL AI-86) receive FDA 510(k) clearance?

A TENS (MODEL AI-86) received FDA 510(k) clearance on 1986-05-16, under 510(k) number K861709.

Who is the listed applicant for A TENS (MODEL AI-86)?

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 A TENS (MODEL AI-86)?

The FDA product code for A TENS (MODEL AI-86) is GZJ.

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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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 PLUSK982221PREMIER APK926326MICROCARE(TM)K912289ULTIMA XS, MODIFICATIONK895295ULTIMA XS MICROCURRENT TENSK894388ZIMMER TENS

View all 11 devices →

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical 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.

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