The following data is part of a premarket notification filed by 21st Century Scientific, Inc. with the FDA for Bounder 300 Power Wheelchair, Bounder Plus 300 Power Wheelchair, Bounder 450 Power Wheelchair, Big Bounder 600 Power Wheelchair, Big Bounder 1000 Power Wheelchair.
| Device ID | K193599 |
| 510k Number | K193599 |
| Device Name: | BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair |
| Classification | Wheelchair, Powered |
| Applicant | 21st Century Scientific, Inc. 4931 N Manufacturing Way Coeur D'alene, ID 83815 |
| Contact | Rd Davidson |
| Correspondent | Rd Davidson 21st Century Scientific, Inc. 4931 N Manufacturing Way Coeur D'alene, ID 83815 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-23 |
| Decision Date | 2020-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861980000479 | K193599 | 000 |
| 00861980000462 | K193599 | 000 |
| 00861980000455 | K193599 | 000 |
| 00861980000448 | K193599 | 000 |
| 00861980000431 | K193599 | 000 |