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FDA 510(k)

EXERCISE BICYCLE

K-Number: K926287 · 1994-03-22

ApplicantHenley Intl.
Decision Date1994-03-22
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EXERCISE BICYCLE is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1994-03-22 under 510(k) number K926287. 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 EXERCISE BICYCLE?

EXERCISE BICYCLE is a medical device that received FDA 510(k) clearance on 1994-03-22. The listed applicant is Henley Intl.. The 510(k) number is K926287.

When did EXERCISE BICYCLE receive FDA 510(k) clearance?

EXERCISE BICYCLE received FDA 510(k) clearance on 1994-03-22, under 510(k) number K926287.

Who is the listed applicant for EXERCISE BICYCLE?

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 EXERCISE BICYCLE?

The FDA product code for EXERCISE BICYCLE 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 DEVICESK926279UPPER BODY EXERCISERK926278STAIR CLIMBERK926314HYDRA 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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