The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Ultimate Contour, Ultimate Contour Mini.
| Device ID | K201475 |
| 510k Number | K201475 |
| Device Name: | Ultimate Contour, Ultimate Contour Mini |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | CAO Group, Inc. 4628 West Skyhawk Drive West Jordan, UT 84084 |
| Contact | Robert K. Larsen |
| Correspondent | Robert K. Larsen CAO Group, Inc. 4628 West Skyhawk Drive West Jordan, UT 84084 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-03 |
| Decision Date | 2020-10-28 |