The following data is part of a premarket notification filed by Nanjing Jin Bai He Medical Apparatus Co., Ltd. with the FDA for Powered Wheelchair Dyw30a(d09).
| Device ID | K170787 |
| 510k Number | K170787 |
| Device Name: | Powered Wheelchair DYW30A(D09) |
| Classification | Wheelchair, Powered |
| Applicant | Nanjing Jin Bai He Medical Apparatus Co., Ltd. No. 61 Qinhuai Road, Jiangning Economic And Technological Development Zone Nanjing, CN 211106 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min Nanjing Jin Bai He Medical Apparatus Co., Ltd. No. 61 Qinhuai Road, Jiangning Economic And Technological Development Zone Nanjing, CN 211106 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-16 |
| Decision Date | 2017-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810058400314 | K170787 | 000 |
| 00810058400307 | K170787 | 000 |
| 06973175532314 | K170787 | 000 |