FDA UDI
In Commercial Distribution
🇺🇸 United States
E-Stim II
DI: 14897076720030
·
Model: ED3922
·
TENS PLUS INDUSTRIAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- E-Stim II
- Primary DI
- 14897076720030
- Version / Model
- ED3922
- Catalog Number
- ED3922
- Company Name
- TENS PLUS INDUSTRIAL COMPANY
- Labeler DUNS
- 663211978
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-04
- Public Version
- 4
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 25513770-e2a7-4284-bcda-cd1788ea219a
Device Description
The E-Stim II® Electro Acup/Micro is the most economical and easy-to-use portable electro-therapy unit. New dual channel, portable, continuous frequency unit features Milli-amp (normal current) and Micro-amp (micro current) settings. Each channel also includes its own green LED light which displays power-on and frequency. Accessories include 2 sets of alligator clip wires, 9 volt battery, and instructions.
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 |
|---|---|---|---|---|
| 35372 | Analgesic transcutaneous electrical nerve stimulation system | An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. 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 use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 14897076720030 | GS1 | ||||
| Package | 34897076720034 | GS1 | Master Case | 30 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-722-8775
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K050435 | 000 |