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FDA 510(k)

STATIONARY EXERCISE BICYCLE

K-Number: K834098 · 1983-12-27

ApplicantEngineering Dynamics Corp.
Decision Date1983-12-27
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STATIONARY EXERCISE BICYCLE is the device name listed in this FDA 510(k) record. The listed applicant is Engineering Dynamics Corp.. It received FDA 510(k) clearance on 1983-12-27 under 510(k) number K834098. 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 STATIONARY EXERCISE BICYCLE?

STATIONARY EXERCISE BICYCLE is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is Engineering Dynamics Corp.. The 510(k) number is K834098.

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

STATIONARY EXERCISE BICYCLE received FDA 510(k) clearance on 1983-12-27, under 510(k) number K834098.

Who is the listed applicant for STATIONARY EXERCISE BICYCLE?

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

What is the FDA product code for STATIONARY EXERCISE BICYCLE?

The FDA product code for STATIONARY EXERCISE BICYCLE is ISD.

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Other records listing Engineering Dynamics 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.

K871494UPPERCYCLE STATIONARY EXERCISE MACHINESK844578NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONAK842108UNIVERSAL EXAMINATION TABLEK828313DIGITAL RADIOGRAPHY EXAMINATION TABLEK802254GENERAL ULTRASOUND EXAM. TABLEK790545STRESS TESTING SYSTEM, LATERAL TILTING

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Related Devices (Code: ISD)

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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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