FDA UDI
In Commercial Distribution
🇺🇸 United States
COMFYTENS
DI: 00816924020266
·
Model: COMFYTENS
·
Tensproducts, LLC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- COMFYTENS
- Primary DI
- 00816924020266
- Version / Model
- COMFYTENS
- Catalog Number
- COMFYTENS, COMFYTENS-JETT, COMFYTENS-TP, COMFYTENS-MFR
- Company Name
- Tensproducts, LLC
- Labeler DUNS
- 104307787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-21
- Public Version
- 5
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- c6099ba3-1bba-438b-a69a-ee277f950498
Device Description
DIGITAL TENS WITH 5 MODES
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
- No
- 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 |
|---|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816924020263 | GS1 | CASE-WITH 4040TC | 32 | In Commercial Distribution | |
| Package | 00816924020396 | GS1 | KIT-WITH 4040TC | 1 | In Commercial Distribution | |
| Primary | 00816924020266 | GS1 | ||||
| Package | 00816924020754 | GS1 | KIT-WITH KWTS22-TP | 1 | In Commercial Distribution | |
| Package | 00816924020808 | GS1 | KIT-WITH KWTS22-MFR | 1 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071951 | 000 |