The following data is part of a premarket notification filed by Accelerated Care Plus Corp. with the FDA for Acp Omnipad Light Therapy System & Acp Omnipad 500 Control Unit.
| Device ID | K060191 |
| 510k Number | K060191 |
| Device Name: | ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | ACCELERATED CARE PLUS CORP. 9855 DOUBLE R BLVD. #100 Reno, NV 89521 |
| Contact | Patrick Parker |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-01-25 |
| Decision Date | 2006-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858703006906 | K060191 | 000 |
| 00858703006061 | K060191 | 000 |