FDA UDI
Not in Commercial Distribution
🇺🇸 United States
WELL-LIFE
DI: 04719872265047
·
Model: WL-2504
·
WELL-LIFE HEALTHCARE LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WELL-LIFE
- Primary DI
- 04719872265047
- Version / Model
- WL-2504
- Company Name
- WELL-LIFE HEALTHCARE LTD.
- Labeler DUNS
- 658608864
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-29
- Public Version
- 5
- Public Version Date
- 2019-05-23
- Public Version Status
- Update
- Public Device Record Key
- 1483195a-7d6c-43e9-998f-504d9324eef9
- Distribution End Date
- 2019-03-29
Device Description
Digital buttons controlled stimulator, with multiple modalities, optional 2 or 4 channels. This Device is only for prescription use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| LIH | Interferential Current Therapy | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46571 | Physical therapy transcutaneous electrical stimulation system, line-powered | An assembly of mains electricity (AC-powered) devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical calf muscle stimulation to prevent venous thrombosis, and/or to maintain or increase range of motion. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719872265047 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100399 | 000 |