FDA UDI
In Commercial Distribution
🇺🇸 United States
Ultimate Contour Mini
DI: 00872320004477
·
Model: 005-00036
·
CAO GROUP, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Ultimate Contour Mini
- Primary DI
- 00872320004477
- Version / Model
- 005-00036
- Company Name
- CAO GROUP, INC.
- Labeler DUNS
- 102422578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-06
- Public Version
- 2
- Public Version Date
- 2025-06-30
- Public Version Status
- Update
- Public Device Record Key
- 832ad484-e4ca-40ba-b313-47117e6bf8bf
Device Description
Non-thermal radio frequency device for relief of minor aches and pains, relief of muscle spasms, temporary improvement in local circulation, and temporary reduction in the appearance of cellulite.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44832 | Multi-modality skin/body contouring system | An assembly of devices intended to use a combination of noninvasive energies and methods to locally reduce the subcutaneous fat layer, cellulite manifestation, and loose or wrinkled skin appearance. It consists of an electrically-powered control unit/generator to produce two or more energy modalities [e.g., radio-frequency, thermal/cryogenic (for cryolipolysis), high intensity focused ultrasound (HIFU), infrared light], and body-surface applicators to apply the treatment to the target area (e.g., chin, hips, abdomen, thighs); some types are additionally capable of applying vacuum. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00872320004460 | GS1 | Kit | 1 | In Commercial Distribution | |
| Primary | 00872320004477 | GS1 |
Customer Contacts
- Phone
- 801-369-9448
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171052 | 000 |