The following data is part of a premarket notification filed by 21st Century Scientific, Inc. with the FDA for Bounder Va Power Wheelchair.
Device ID | K901210 |
510k Number | K901210 |
Device Name: | BOUNDER VA POWER WHEELCHAIR |
Classification | Wheelchair, Powered |
Applicant | 21ST CENTURY SCIENTIFIC, INC. 7629 FULTON AVE. North Hollywood, CA 91605 |
Contact | Prior, Phd |
Correspondent | Prior, Phd 21ST CENTURY SCIENTIFIC, INC. 7629 FULTON AVE. North Hollywood, CA 91605 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-14 |
Decision Date | 1990-03-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00861980000424 | K901210 | 000 |
00861980000417 | K901210 | 000 |
00861980000400 | K901210 | 000 |