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FDA 510(k)

UPPER BODY EXERCISER

K-Number: K926279 · 1994-05-05

ApplicantHenley Intl.
Decision Date1994-05-05
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

UPPER BODY EXERCISER is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1994-05-05 under 510(k) number K926279. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UPPER BODY EXERCISER?

UPPER BODY EXERCISER is a medical device that received FDA 510(k) clearance on 1994-05-05. The listed applicant is Henley Intl.. The 510(k) number is K926279.

When did UPPER BODY EXERCISER receive FDA 510(k) clearance?

UPPER BODY EXERCISER received FDA 510(k) clearance on 1994-05-05, under 510(k) number K926279.

Who is the listed applicant for UPPER BODY EXERCISER?

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 UPPER BODY EXERCISER?

The FDA product code for UPPER BODY EXERCISER is ISD.

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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 CLIMBERK926287EXERCISE BICYCLEK926314HYDRA FITNESS MODEL 311 TOTAL POWERK926313COMPUTERIZED TESTING AND EXERCISE SYSTEMSK915864MONOTRODE CUTANEOUS ELECTRODE

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Related Devices (Code: ISD)

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.

K202979MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal UltraLode B.V.K183296REAL Immersive SystemPenumbra, Inc.K112121ERGOSELECT/GEErgoline GmbHK080545ACTITRAINERActigraph, LLCK053078ERGOSELECT 100 K/P, ERGOSELECT 200 K/PErgoline GmbHK990866QUINTON MEDTRACK CR PLUS TREADMILLQuinton, Inc.

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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