FDA UDI
In Commercial Distribution
🇺🇸 United States
AURAWAVE
DI: 00628055644002
·
Model: AWDD
·
ENDURANCE THERAPEUTICS INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AURAWAVE
- Primary DI
- 00628055644002
- Version / Model
- AWDD
- Company Name
- ENDURANCE THERAPEUTICS INC.
- Labeler DUNS
- 963843318
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-28
- Public Version
- 3
- Public Version Date
- 2019-03-11
- Public Version Status
- Update
- Public Device Record Key
- 490fdbe2-b0f4-47fb-b45b-e3e3e76db098
Device Description
T.E.N.S. Device ; Pain Relief Therapy Kit.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | 882.5890 | 2 |
| NYN | Stimulator, Electrical, Transcutaneous, For Arthritis | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46463 | Arthritis TENS system | An assembly of battery-powered devices intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneously). It typically consists of an external electric current generator and electrodes that are placed on the skin near a joint(s) to provide the electrical stimulus to the painful area. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for routine home-use to treat symptoms of rheumatoid arthritis (RA) of the hands and osteoarthritis of the knee. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628055644002 | GS1 |
Customer Contacts
- Phone
- 888.358.7145
- [email protected]