The following data is part of a premarket notification filed by Health Products, Inc. with the FDA for Orthoderm Convertible.
| Device ID | K894353 |
| 510k Number | K894353 |
| Device Name: | ORTHODERM CONVERTIBLE |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | HEALTH PRODUCTS, INC. 747 KENRICK, #116 Houston, TX 77060 |
| Contact | Jack H Hess |
| Correspondent | Jack H Hess HEALTH PRODUCTS, INC. 747 KENRICK, #116 Houston, TX 77060 |
| Product Code | IOQ |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-08-09 |