K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))
FDA 510(k) clearance K260319 · decided 2026-03-31
Clearance details
- K-number
- K260319
- Device name
- K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))
- Applicant
- Zhenjiang Assure Medical Equipment Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-01-30
- Decision date
- 2026-03-31
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Zhenjiang, CN
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Manual Wheelchair (H008, PCK7) (K261571) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-08-06 |
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| Helio Kids; Apex P (K260295) | Motion Composites | 2026-05-28 |
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| Manual Wheelchair (W50) (K253632) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2026-01-29 |
| EmpowerRide NAVIGATOR (K251886) | Empower Ride, LLC | 2026-01-12 |
| Manual Wheelchair (W45) (K252825) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 |
Recalls involving this device
No recalls on record reference this clearance.