The following data is part of a premarket notification filed by O'tec Corp. with the FDA for Wheelchair Bcw 6000.
| Device ID | K883034 |
| 510k Number | K883034 |
| Device Name: | WHEELCHAIR BCW 6000 |
| Classification | Wheelchair, Mechanical |
| Applicant | O'TEC CORP. 612 EAST ASH P.O. BOX DRAWER 30 Oberlin, KS 67749 |
| Contact | Steve P Brungardt |
| Correspondent | Steve P Brungardt O'TEC CORP. 612 EAST ASH P.O. BOX DRAWER 30 Oberlin, KS 67749 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-19 |
| Decision Date | 1988-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845699001354 | K883034 | 000 |
| 00845699000104 | K883034 | 000 |
| 00845699000111 | K883034 | 000 |
| 00845699000128 | K883034 | 000 |
| 00845699000135 | K883034 | 000 |
| 00845699000142 | K883034 | 000 |
| 00845699000159 | K883034 | 000 |
| 00845699000166 | K883034 | 000 |
| 00845699000555 | K883034 | 000 |
| 00845699000098 | K883034 | 000 |