The following data is part of a premarket notification filed by Jerry Medical Instrument (shanghai) Co., Ltd. with the FDA for Manual Wheelchair.
| Device ID | K192658 |
| 510k Number | K192658 |
| Device Name: | Manual Wheelchair |
| Classification | Wheelchair, Mechanical |
| Applicant | Jerry Medical Instrument (Shanghai) Co., Ltd. Building 12, No. 615 Fengdeng Rd, Malu Town, Jiading District Shanghai, CN 201801 |
| Contact | Jianguo Chen |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-25 |
| Decision Date | 2020-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06934374100230 | K192658 | 000 |
| 06934374100223 | K192658 | 000 |
| 06934374100216 | K192658 | 000 |
| 06934374100209 | K192658 | 000 |