The following data is part of a premarket notification filed by Labac Systems, Inc. with the FDA for Reduced Shear Owr Recline System.
| Device ID | K923362 |
| 510k Number | K923362 |
| Device Name: | REDUCED SHEAR OWR RECLINE SYSTEM |
| Classification | Wheelchair, Powered |
| Applicant | LABAC SYSTEMS, INC. 8955 SOUTH RIDGELINE BOULEVARD Highlands Ranch, CO 80126 |
| Contact | Peter Zeeb |
| Correspondent | Peter Zeeb LABAC SYSTEMS, INC. 8955 SOUTH RIDGELINE BOULEVARD Highlands Ranch, CO 80126 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-08 |
| Decision Date | 1993-03-26 |