The following data is part of a premarket notification filed by Lumex, Inc. with the FDA for Akrotech 4000.
| Device ID | K923977 |
| 510k Number | K923977 |
| Device Name: | AKROTECH 4000 |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
| Contact | Joseph Mueller |
| Correspondent | Joseph Mueller LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
| Product Code | IOQ |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-07 |
| Decision Date | 1993-02-12 |