The following data is part of a premarket notification filed by Roc Chinese-european Industrial Research Society with the FDA for Biotech Powered Wheelchair, C650pw.
| Device ID | K011846 |
| 510k Number | K011846 |
| Device Name: | BIOTECH POWERED WHEELCHAIR, C650PW |
| Classification | Wheelchair, Powered |
| Applicant | ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY NO.58, FU-CHIUN STREET, Hsin-chu City, TW |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY NO.58, FU-CHIUN STREET, Hsin-chu City, TW |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-12 |
| Decision Date | 2002-01-18 |