FDA 510(k)

e-Throne Folding Wheelchair, Model: ET-12F22

Numéro K : K191105 · 2022-01-21

DemandeurGolden Motor Technology Co., Ltd.

Date de décision2022-01-21

Code produitITI

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

e-Throne Folding Wheelchair, Model: ET-12F22 is the device name listed in this FDA 510(k) record. The listed applicant is Golden Motor Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-21 under 510(k) number K191105. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the e-Throne Folding Wheelchair, Model: ET-12F22?

e-Throne Folding Wheelchair, Model: ET-12F22 is a medical device that received FDA 510(k) clearance on 2022-01-21. The listed applicant is Golden Motor Technology Co., Ltd.. The 510(k) number is K191105.

When did e-Throne Folding Wheelchair, Model: ET-12F22 receive FDA 510(k) clearance?

e-Throne Folding Wheelchair, Model: ET-12F22 received FDA 510(k) clearance on 2022-01-21, under 510(k) number K191105.

Who is the listed applicant for e-Throne Folding Wheelchair, Model: ET-12F22?

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

What is the FDA product code for e-Throne Folding Wheelchair, Model: ET-12F22?

The FDA product code for e-Throne Folding Wheelchair, Model: ET-12F22 is ITI.

Essais cliniques associés

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Dispositifs connexes (Code : ITI)

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Source officielle

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