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FDA 510(k)

TEAM-MC II

K-Number: K921828 · 1992-09-22

ApplicantHenley Intl.
Decision Date1992-09-22
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TEAM-MC II is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1992-09-22 under 510(k) number K921828. 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 TEAM-MC II?

TEAM-MC II is a medical device that received FDA 510(k) clearance on 1992-09-22. The listed applicant is Henley Intl.. The 510(k) number is K921828.

When did TEAM-MC II receive FDA 510(k) clearance?

TEAM-MC II received FDA 510(k) clearance on 1992-09-22, under 510(k) number K921828.

Who is the listed applicant for TEAM-MC II?

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

What is the FDA product code for TEAM-MC II?

The FDA product code for TEAM-MC II is GZJ.

Other records listing Henley Intl. 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.

K943449NEUROLOGICAL DIAGNOSTIC DEVICESK926278STAIR CLIMBERK926279UPPER BODY EXERCISERK926287EXERCISE BICYCLEK926314HYDRA FITNESS MODEL 311 TOTAL POWERK926313COMPUTERIZED TESTING AND EXERCISE SYSTEMS

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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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