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FDA 510(k)

Aimanfun Lumea Comfort, A-2789/A-3588

K-Number: K212907 · 2021-12-02

ApplicantKam Yuen Plastic Products , Ltd.
Decision Date2021-12-02
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aimanfun Lumea Comfort, A-2789/A-3588 is the device name listed in this FDA 510(k) record. The listed applicant is Kam Yuen Plastic Products , Ltd.. It received FDA 510(k) clearance on 2021-12-02 under 510(k) number K212907. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aimanfun Lumea Comfort, A-2789/A-3588?

Aimanfun Lumea Comfort, A-2789/A-3588 is a medical device that received FDA 510(k) clearance on 2021-12-02. The listed applicant is Kam Yuen Plastic Products , Ltd.. The 510(k) number is K212907.

When did Aimanfun Lumea Comfort, A-2789/A-3588 receive FDA 510(k) clearance?

Aimanfun Lumea Comfort, A-2789/A-3588 received FDA 510(k) clearance on 2021-12-02, under 510(k) number K212907.

Who is the listed applicant for Aimanfun Lumea Comfort, A-2789/A-3588?

The FDA 510(k) record lists Kam Yuen Plastic Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aimanfun Lumea Comfort, A-2789/A-3588?

The FDA product code for Aimanfun Lumea Comfort, A-2789/A-3588 is ONF.

Other records listing Kam Yuen Plastic Products , Ltd. 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.

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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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