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FDA 510(k)

ELITE LIGHTWEIGHT WHEELCHAIR

K-Number: K974197 · 1997-12-17

ApplicantJaken Co., Inc.
Decision Date1997-12-17
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELITE LIGHTWEIGHT WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Jaken Co., Inc.. It received FDA 510(k) clearance on 1997-12-17 under 510(k) number K974197. 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 ELITE LIGHTWEIGHT WHEELCHAIR?

ELITE LIGHTWEIGHT WHEELCHAIR is a medical device that received FDA 510(k) clearance on 1997-12-17. The listed applicant is Jaken Co., Inc.. The 510(k) number is K974197.

When did ELITE LIGHTWEIGHT WHEELCHAIR receive FDA 510(k) clearance?

ELITE LIGHTWEIGHT WHEELCHAIR received FDA 510(k) clearance on 1997-12-17, under 510(k) number K974197.

Who is the listed applicant for ELITE LIGHTWEIGHT WHEELCHAIR?

The FDA 510(k) record lists Jaken Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELITE LIGHTWEIGHT WHEELCHAIR?

The FDA product code for ELITE LIGHTWEIGHT WHEELCHAIR is IOR.

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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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