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FDA 510(k)

COM-TENS: A NEUROSTIMULATOR

K-Number: K902102 · 1991-05-30

ApplicantApex Medical, Inc.
Decision Date1991-05-30
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COM-TENS: A NEUROSTIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical, Inc.. It received FDA 510(k) clearance on 1991-05-30 under 510(k) number K902102. 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 COM-TENS: A NEUROSTIMULATOR?

COM-TENS: A NEUROSTIMULATOR is a medical device that received FDA 510(k) clearance on 1991-05-30. The listed applicant is Apex Medical, Inc.. The 510(k) number is K902102.

When did COM-TENS: A NEUROSTIMULATOR receive FDA 510(k) clearance?

COM-TENS: A NEUROSTIMULATOR received FDA 510(k) clearance on 1991-05-30, under 510(k) number K902102.

Who is the listed applicant for COM-TENS: A NEUROSTIMULATOR?

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

What is the FDA product code for COM-TENS: A NEUROSTIMULATOR?

The FDA product code for COM-TENS: A NEUROSTIMULATOR is GZJ.

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Other records listing Apex Medical, Inc. 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.

K933965APEX MEDICAL AIR PUMPSK882816PULSAR EMK882468ELIMINATOR AIR FILTERK871570APEX ALPHA VACUUM PUMPK871384APEX SUCTION CURETTE

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

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

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