The following data is part of a premarket notification filed by Physio Designs, Inc. with the FDA for Physio/1000.
| Device ID | K974070 |
| 510k Number | K974070 |
| Device Name: | PHYSIO/1000 |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | PHYSIO DESIGNS, INC. 11 ARDEN LN. Commack, NY 11725 |
| Contact | James M Terracciano |
| Correspondent | James M Terracciano PHYSIO DESIGNS, INC. 11 ARDEN LN. Commack, NY 11725 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-28 |
| Decision Date | 1998-01-06 |