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FDA 510(k)

MICRO II MICROCURRENT TENS

K-Number: K973978 · 1998-07-29

ApplicantApex Medical Corp.
Decision Date1998-07-29
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MICRO II MICROCURRENT TENS is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical Corp.. It received FDA 510(k) clearance on 1998-07-29 under 510(k) number K973978. 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 MICRO II MICROCURRENT TENS?

MICRO II MICROCURRENT TENS is a medical device that received FDA 510(k) clearance on 1998-07-29. The listed applicant is Apex Medical Corp.. The 510(k) number is K973978.

When did MICRO II MICROCURRENT TENS receive FDA 510(k) clearance?

MICRO II MICROCURRENT TENS received FDA 510(k) clearance on 1998-07-29, under 510(k) number K973978.

Who is the listed applicant for MICRO II MICROCURRENT TENS?

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

What is the FDA product code for MICRO II MICROCURRENT TENS?

The FDA product code for MICRO II MICROCURRENT TENS is GZJ.

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Other records listing Apex Medical Corp. as applicant

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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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