FDA UDI
In Commercial Distribution
🇺🇸 United States
Biomega Digital Tens Unit
DI: 00694202908402
·
Model: 1653195
·
INNOVAGE LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Biomega Digital Tens Unit
- Primary DI
- 00694202908402
- Version / Model
- 1653195
- Catalog Number
- 1653195
- Company Name
- INNOVAGE LLC
- Labeler DUNS
- 603091281
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-30
- Public Version
- 7
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 4cc59e60-4bd7-40d8-878e-e727fe625dfe
Device Description
Transcutaneous Electrical Nerve Stimulation
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|---|---|
| Primary | 00694202908402 | GS1 |
Customer Contacts
- Phone
- 877-630-9788
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -4 – 131 Degrees Fahrenheit