SUNCO Mechanical Wheelchair, model SKW-9003

by Danyang Sunco Machinery Co.ltd

510(k) K153328

Listed No authorization on record

Valid until

Not applicable

No authorization on record

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 7 Oct 2026. What this means

Specification

510(k)

510(k) Number: K153328
FDA Product Code: IOR
FDA applicant: Danyang Sunco Machinery Co., Ltd.

Device Class: Class I
Regulation: 21 CFR Part 890.3850
Advisory Committee: Physical Medicine
FDA Decision: SESE Substantially Equivalent

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