The following data is part of a premarket notification filed by Merits Healthcare Industries (suzhou) Co., Ltd. with the FDA for Merits Model R106/r136 Rehab Wheelchair.
| Device ID | K170517 |
| 510k Number | K170517 |
| Device Name: | Merits Model R106/R136 Rehab Wheelchair |
| Classification | Wheelchair, Mechanical |
| Applicant | Merits Healthcare Industries (suzhou) Co., LTD. No.29, Fuzhou Road Taicang City, CN 215411 |
| Contact | Guangyong Li |
| Correspondent | Guangyong Li Merits Healthcare Industries (suzhou) Co., LTD. No.29, Fuzhou Road Taicang City, CN 215411 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-21 |
| Decision Date | 2017-11-16 |
| Summary: | summary |