FDA UDI
In Commercial Distribution
🇺🇸 United States
EmFace or Evoke
DI: 07290016633504
·
Model: AG608082A
·
INMODE M.D LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EmFace or Evoke
- Primary DI
- 07290016633504
- Version / Model
- AG608082A
- Catalog Number
- AG608082A
- Company Name
- INMODE M.D LTD
- Labeler DUNS
- 600417351
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-27
- Public Version
- 1
- Public Version Date
- 2022-11-04
- Public Version Status
- New
- Public Device Record Key
- 33b03b14-68fb-4292-8b98-43f356d97eb1
Device Description
The EmFace Device with the Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
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
- Yes
- 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 |
|---|---|---|---|---|
| 58456 | Radio-frequency skin surface treatment/fat liquefaction system control unit | A mains electricity (AC-powered) device designed to supply radio-frequency (RF) energy to dedicated applicators (handpieces) for skin surface treatment and fat liquefaction procedures. It typically includes an RF generator, user interface/controls, and inputs for other system components. It typically provides continuous tissue temperature monitoring, and impedance and power monitoring with tissue overheating safety systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016633504 | GS1 |
Customer Contacts
- Phone
- 1-887-367-4556
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191855 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 65 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 110 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 90 – 110 KiloPascal