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 |