The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Neo-wave System.
| Device ID | K810543 |
| 510k Number | K810543 |
| Device Name: | NEO-WAVE SYSTEM |
| Classification | Bed, Air Fluidized |
| Applicant | GAYMAR INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | INX |
| CFR Regulation Number | 890.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-27 |
| Decision Date | 1981-03-06 |