The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Lifestyle Sof. Care Gel Chair Cushion.
| Device ID | K882012 |
| 510k Number | K882012 |
| Device Name: | LIFESTYLE SOF. CARE GEL CHAIR CUSHION |
| Classification | Components, Wheelchair |
| Applicant | GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Contact | Peter Powell |
| Correspondent | Peter Powell GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Product Code | KNN |
| CFR Regulation Number | 890.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-13 |
| Decision Date | 1988-05-23 |