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FDA 510(k)

PULSESTAR EXERCISE BIKE

K-Number: K863884 · 1986-10-23

ApplicantBattle Creek Equipment Co.
Decision Date1986-10-23
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PULSESTAR EXERCISE BIKE 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 1986-10-23 under 510(k) number K863884. 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 PULSESTAR EXERCISE BIKE?

PULSESTAR EXERCISE BIKE is a medical device that received FDA 510(k) clearance on 1986-10-23. The listed applicant is Battle Creek Equipment Co.. The 510(k) number is K863884.

When did PULSESTAR EXERCISE BIKE receive FDA 510(k) clearance?

PULSESTAR EXERCISE BIKE received FDA 510(k) clearance on 1986-10-23, under 510(k) number K863884.

Who is the listed applicant for PULSESTAR EXERCISE BIKE?

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 PULSESTAR EXERCISE BIKE?

The FDA product code for PULSESTAR EXERCISE BIKE is ISD.

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Other records listing Battle Creek Equipment Co. 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.

K882264BATTLE CREEK PILLOWK854147BATTLE CREEK BOARDWALKER ELECTRIC TREADMILLK854148BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILLK851237THERMOPHORE ELECTRIC FOMENTATION UNITK840280ROAD RUNNER ELECTRIC TREADMILLK791866STANDARD HEALTH BIKE MODEL 019

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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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