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FDA 510(k)

WHEELCHAIR, MODEL 8500-II

K-Number: K043332 · 2004-12-13

ApplicantCycling and Health Tech. Industry R&D Center
Decision Date2004-12-13
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WHEELCHAIR, MODEL 8500-II is the device name listed in this FDA 510(k) record. The listed applicant is Cycling and Health Tech. Industry R&D Center. It received FDA 510(k) clearance on 2004-12-13 under 510(k) number K043332. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WHEELCHAIR, MODEL 8500-II?

WHEELCHAIR, MODEL 8500-II is a medical device that received FDA 510(k) clearance on 2004-12-13. The listed applicant is Cycling and Health Tech. Industry R&D Center. The 510(k) number is K043332.

When did WHEELCHAIR, MODEL 8500-II receive FDA 510(k) clearance?

WHEELCHAIR, MODEL 8500-II received FDA 510(k) clearance on 2004-12-13, under 510(k) number K043332.

Who is the listed applicant for WHEELCHAIR, MODEL 8500-II?

The FDA 510(k) record lists Cycling and Health Tech. Industry R&D Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WHEELCHAIR, MODEL 8500-II?

The FDA product code for WHEELCHAIR, MODEL 8500-II is IOR.

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Other records listing Cycling and Health Tech. Industry R&D Center as applicant

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Related Devices (Code: IOR)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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