SHENGGUANG MANUAL WHEELCHAIR
FDA 510(k) clearance K131529 · decided 2013-09-24
Clearance details
- K-number
- K131529
- Device name
- SHENGGUANG MANUAL WHEELCHAIR
- Applicant
- Pingdingshan Shenxing Healthcare Technology Co., L
- Decision
- Substantially Equivalent
- Date received
- 2013-05-28
- Decision date
- 2013-09-24
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Pingdingshan City, Henan, CN
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pingdingshan Shenxing Healthcare Technology Co.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.