FDA 510(k)

STANDARD HEALTH BIKE MODEL 019

K-Number: K791866 · 1979-10-04

Decision Date1979-10-04

Product CodeISD

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

STANDARD HEALTH BIKE MODEL 019 is the device name listed in this FDA 510(k) record. The listed applicant is Battle Creek Equipment Co.. It received FDA 510(k) clearance on 1979-10-04 under 510(k) number K791866. 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 STANDARD HEALTH BIKE MODEL 019?

STANDARD HEALTH BIKE MODEL 019 is a medical device that received FDA 510(k) clearance on 1979-10-04. The listed applicant is Battle Creek Equipment Co.. The 510(k) number is K791866.

When did STANDARD HEALTH BIKE MODEL 019 receive FDA 510(k) clearance?

STANDARD HEALTH BIKE MODEL 019 received FDA 510(k) clearance on 1979-10-04, under 510(k) number K791866.

Who is the listed applicant for STANDARD HEALTH BIKE MODEL 019?

The FDA 510(k) record lists Battle Creek Equipment Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STANDARD HEALTH BIKE MODEL 019?

The FDA product code for STANDARD HEALTH BIKE MODEL 019 is ISD.

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Other records listing Battle Creek Equipment Co. as applicant

K882264BATTLE CREEK PILLOW K863884PULSESTAR EXERCISE BIKE K854147BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL K854148BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL K851237THERMOPHORE ELECTRIC FOMENTATION UNIT K840280ROAD RUNNER ELECTRIC TREADMILL

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Related Devices (Code: ISD)

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 GmbH K080545ACTITRAINERActigraph, LLC K053078ERGOSELECT 100 K/P, ERGOSELECT 200 K/PErgoline GmbH K990866QUINTON 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.