The following data is part of a premarket notification filed by Foshan Dongfang Medical Equipment Manufactory(ltd) with the FDA for Fs Series Wheelchair.
| Device ID | K041814 |
| 510k Number | K041814 |
| Device Name: | FS SERIES WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY(LTD) 2 BAOHUA INDUSTRIAL PARK AV. GUILAN RD. NANHAI DISTRICT Foshan, Guangdong Province, CN 528252 |
| Contact | Pang Jianxun |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-07-06 |
| Decision Date | 2004-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938001012187 | K041814 | 000 |
| 00850051333295 | K041814 | 000 |
| 00850051333301 | K041814 | 000 |
| 06938001010183 | K041814 | 000 |
| 06938001010220 | K041814 | 000 |
| 06938001010664 | K041814 | 000 |
| 06938001011470 | K041814 | 000 |
| 06938001011524 | K041814 | 000 |
| 06938001011920 | K041814 | 000 |
| 06938001011944 | K041814 | 000 |
| 00850051333288 | K041814 | 000 |