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FDA 510(k)

ACUSOURCE 600 (TENS)

K-Number: K895977 · 1990-01-09

ApplicantMicrocurrent Research, Inc.
Decision Date1990-01-09
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACUSOURCE 600 (TENS) is the device name listed in this FDA 510(k) record. The listed applicant is Microcurrent Research, Inc.. It received FDA 510(k) clearance on 1990-01-09 under 510(k) number K895977. 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 ACUSOURCE 600 (TENS)?

ACUSOURCE 600 (TENS) is a medical device that received FDA 510(k) clearance on 1990-01-09. The listed applicant is Microcurrent Research, Inc.. The 510(k) number is K895977.

When did ACUSOURCE 600 (TENS) receive FDA 510(k) clearance?

ACUSOURCE 600 (TENS) received FDA 510(k) clearance on 1990-01-09, under 510(k) number K895977.

Who is the listed applicant for ACUSOURCE 600 (TENS)?

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

What is the FDA product code for ACUSOURCE 600 (TENS)?

The FDA product code for ACUSOURCE 600 (TENS) 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 Microcurrent Research, 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.

K981976ACUTRON MENTOR MODEL 961K901902ACUSOURCE 600 FOR USE WITH TMJ ELECTRODEK890143ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON

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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