The following data is part of a premarket notification filed by Sichuan Ast Medical Equipment Co., Ltd. with the FDA for Ast Model Ma012 And Ms019 Rehab Wheelchair.
| Device ID | K181795 |
| 510k Number | K181795 |
| Device Name: | AST Model MA012 And MS019 Rehab Wheelchair |
| Classification | Wheelchair, Mechanical |
| Applicant | Sichuan AST Medical Equipment Co., Ltd. No.58, Jin-Peng Road, C Area, Luxian Industrial Park Luzhou City, CN 646100 |
| Contact | Johnson Van |
| Correspondent | Johnson Van Sichuan AST Medical Equipment Co., Ltd. No.58, Jin-Peng Road, C Area, Luxian Industrial Park Luzhou City, CN 646100 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-05 |
| Decision Date | 2018-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822383012926 | K181795 | 000 |
| 00822383005263 | K181795 | 000 |
| 00822383005270 | K181795 | 000 |
| 00822383005287 | K181795 | 000 |
| 00822383005294 | K181795 | 000 |
| 00822383005300 | K181795 | 000 |
| 00822383005317 | K181795 | 000 |
| 00822383005324 | K181795 | 000 |
| 00822383008288 | K181795 | 000 |
| 00822383008615 | K181795 | 000 |
| 00822383008981 | K181795 | 000 |
| 00822383008998 | K181795 | 000 |
| 00822383009001 | K181795 | 000 |
| 00822383012384 | K181795 | 000 |
| 00822383005256 | K181795 | 000 |