The following data is part of a premarket notification filed by Anhui Jbh Medical Apparatus Co., Ltd with the FDA for Portable Folding Electric Wheelchair (model: Dc01).
| Device ID | K212092 |
| 510k Number | K212092 |
| Device Name: | Portable Folding Electric Wheelchair (Model: DC01) |
| Classification | Wheelchair, Powered |
| Applicant | Anhui JBH Medical Apparatus Co., Ltd No. 116 Qicang Road Mingguang City, Chuzhou, CN 239400 |
| Contact | Yang Dandan |
| Correspondent | Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, No.1500, Century Ave., Pudong New District Shanghai, CN 200122 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-06 |
| Decision Date | 2022-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973175530457 | K212092 | 000 |
| 06973175530464 | K212092 | 000 |