SUNCO Mechanical Wheelchair, model SKW-9003
FDA 510(k) clearance K153328 · decided 2016-07-20
Clearance details
- K-number
- K153328
- Device name
- SUNCO Mechanical Wheelchair, model SKW-9003
- Applicant
- Danyang Sunco Machinery Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-11-19
- Decision date
- 2016-07-20
- Days to decision
- 244 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Danyang City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.