FDA 510(k) clearance · back to tracker

Manual Wheelchair (SYIV100A008)

Ningbo Shenyu Medical Equipment Co.,Ltd cleared K252517 on 2025-10-03, decision: substantially equivalent

K-number

K252517

Sponsor

Ningbo Shenyu Medical Equipment Co.,Ltd

Device

Manual Wheelchair (SYIV100A008)

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-10-03

Product code

IOR

Advisory committee

Physical Medicine

Medical specialty

Physical Medicine

Regulation number

890.3850

Official FDA record

Open K252517on accessdata.fda.gov →

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

openFDA JSON

Raw record →

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

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Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

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