FDA 510(k) clearance · back to tracker

Manual Wheelchair (H008, PCK7)

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. cleared K261571 on 2026-08-06, decision: substantially equivalent

K-number

K261571

Sponsor

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Device

Manual Wheelchair (H008, PCK7)

Class

Class I

Decision

Substantially Equivalent

Decision date

2026-08-06

Product code

IOR

Advisory committee

Physical Medicine

Medical specialty

Physical Medicine

Regulation number

890.3850

Official FDA record

Open K261571on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.