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510(k) Data Aggregation

K Number

Device Name

Manual Wheelchair (SYIV100A008)

Manufacturer

Ningbo Shenyu Medical Equipment Co.,Ltd

Date Cleared

2025-10-03

(53 days)

Product Code

Regulation Number

Type

Panel

Physical Medicine

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The manual wheelchair is to provide mobility to persons limited to a sitting position.

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