FDA 510(k) clearance · back to tracker

Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)

Anhui Jbh Medical Apparatus Co., Ltd. cleared K241374 on 2025-02-28, decision: substantially equivalent

K-number

K241374

Sponsor

Anhui Jbh Medical Apparatus Co., Ltd.

Device

Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-02-28

Product code

IOR

Advisory committee

Physical Medicine

Medical specialty

Physical Medicine

Regulation number

890.3850

Official FDA record

Open K241374on 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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Drop K241374 into Compass and start a substantial-equivalence draft.

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.