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 |