Manual Wheelchair (Model W28)
FDA 510(k) clearance K200466 · decided 2021-06-14
Clearance details
- K-number
- K200466
- Device name
- Manual Wheelchair (Model W28)
- Applicant
- Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-02-26
- Decision date
- 2021-06-14
- Days to decision
- 474 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Danyang, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.