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FDA 510(k)

TENSTAR

K-Number: K874818 · 1988-09-28

ApplicantHealthcheck Corp.
Decision Date1988-09-28
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENSTAR is the device name listed in this FDA 510(k) record. The listed applicant is Healthcheck Corp.. It received FDA 510(k) clearance on 1988-09-28 under 510(k) number K874818. 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 TENSTAR?

TENSTAR is a medical device that received FDA 510(k) clearance on 1988-09-28. The listed applicant is Healthcheck Corp.. The 510(k) number is K874818.

When did TENSTAR receive FDA 510(k) clearance?

TENSTAR received FDA 510(k) clearance on 1988-09-28, under 510(k) number K874818.

Who is the listed applicant for TENSTAR?

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

What is the FDA product code for TENSTAR?

The FDA product code for TENSTAR is GZJ.

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Other records listing Healthcheck Corp. 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.

K884489C&T PREGNANCY TEST KITK881003DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1K863181HEALTHCHECK THERM-STRIPK861946PTK PLUS. HOME PREGNANCY TESTK860287PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3K851379HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2

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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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