The following data is part of a premarket notification filed by Accelerated Care Plus (acp) with the FDA for Omniversa Multi-modality Therapy System And Omnistim Fx2 Professional Therapy System.
| Device ID | K153559 |
| 510k Number | K153559 |
| Device Name: | OmniVersa Multi-Modality Therapy System And Omnistim FX2 Professional Therapy System |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | Accelerated Care Plus (ACP) 4999 Aircenter Circle, Ste. 103 Reno, NV 89502 |
| Contact | Patrick Parker |
| Correspondent | Patrick Parker Accelerated Care Plus (ACP) 4999 Aircenter Circle, Ste. 103 Reno, NV 89502 |
| Product Code | IMG |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | IPF |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-14 |
| Decision Date | 2016-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858703006139 | K153559 | 000 |