The following data is part of a premarket notification filed by Pingdingshan Shenxing Healthcare Technology Co., L with the FDA for Shengguang Manual Wheelchair.
| Device ID | K131529 |
| 510k Number | K131529 |
| Device Name: | SHENGGUANG MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | PINGDINGSHAN SHENXING HEALTHCARE TECHNOLOGY CO., L XINXING RD. SOUTH OF INDUSTRIAL PARK LUSHAN COUNTY Pingdingshan City, Henan, CN |
| Contact | Wang Qing |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-05-28 |
| Decision Date | 2013-09-24 |
| Summary: | summary |