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FDA 510(k)

MECHANICAL WHEELCHAIR

K-Number: K120032 · 2012-04-13

ApplicantAikin Healthcare Co., Ltd.
Decision Date2012-04-13
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MECHANICAL WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Aikin Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2012-04-13 under 510(k) number K120032. 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 MECHANICAL WHEELCHAIR?

MECHANICAL WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2012-04-13. The listed applicant is Aikin Healthcare Co., Ltd.. The 510(k) number is K120032.

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

MECHANICAL WHEELCHAIR received FDA 510(k) clearance on 2012-04-13, under 510(k) number K120032.

Who is the listed applicant for MECHANICAL WHEELCHAIR?

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

What is the FDA product code for MECHANICAL WHEELCHAIR?

The FDA product code for MECHANICAL 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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