FDA 510(k) clearance · back to tracker

Manual Wheelchair (HM305-Air1, HM305-Air2)

Suzhou Master Machinery Manufacturing Co.,Ltd cleared K252687 on 2025-11-21, decision: substantially equivalent

K-number

K252687

Sponsor

Suzhou Master Machinery Manufacturing Co.,Ltd

Device

Manual Wheelchair (HM305-Air1, HM305-Air2)

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-11-21

Product code

IOR

Advisory committee

Physical Medicine

Medical specialty

Physical Medicine

Regulation number

890.3850

Official FDA record

Open K252687on 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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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.