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FDA 510(k)

INNOVA WHEELCHAIR

K-Number: K110788 · 2011-05-06

ApplicantColumbia Medical Manufacturing, LLC
Decision Date2011-05-06
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INNOVA WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Columbia Medical Manufacturing, LLC. It received FDA 510(k) clearance on 2011-05-06 under 510(k) number K110788. 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 INNOVA WHEELCHAIR?

INNOVA WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2011-05-06. The listed applicant is Columbia Medical Manufacturing, LLC. The 510(k) number is K110788.

When did INNOVA WHEELCHAIR receive FDA 510(k) clearance?

INNOVA WHEELCHAIR received FDA 510(k) clearance on 2011-05-06, under 510(k) number K110788.

Who is the listed applicant for INNOVA WHEELCHAIR?

The FDA 510(k) record lists Columbia Medical Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNOVA WHEELCHAIR?

The FDA product code for INNOVA 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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