FDA UDI
In Commercial Distribution
🇺🇸 United States
ApexRF Applicator
DI: 07290019863359
·
Model: AG614409A
·
INMODE M.D LTD
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ApexRF Applicator
- Primary DI
- 07290019863359
- Version / Model
- AG614409A
- Catalog Number
- AG614409A
- Company Name
- INMODE M.D LTD
- Labeler DUNS
- 600417351
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-04
- Public Version
- 1
- Public Version Date
- 2025-06-12
- Public Version Status
- New
- Public Device Record Key
- 78f407b3-cf44-4314-9511-0b48cd2b5211
Device Description
ApexRF handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | General, Plastic Surgery | 878.4400 | 2 |
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
| NUV | Massager, Vacuum, Light Induced Heating | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35156 | Percutaneous radio-frequency ablation system generator | An electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290019863359 | GS1 |
Customer Contacts
- Phone
- 18873674556
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210492 | 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
- Handling Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 90 – 110 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 110 KiloPascal