FDA UDI
Not in Commercial Distribution
🇺🇸 United States
WELLNESSPRO
DI: B243SSWP2010PLUS0
·
Model: 2010 PLUS
·
ELECTRO MEDICAL TECHNOLOGIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WELLNESSPRO
- Primary DI
- B243SSWP2010PLUS0
- Version / Model
- 2010 PLUS
- Company Name
- ELECTRO MEDICAL TECHNOLOGIES, LLC
- Labeler DUNS
- 160641309
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-21
- Public Version
- 5
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 2b407420-2105-43f5-807a-6d03a6f10a2d
- Distribution End Date
- 2018-06-23
Device Description
Transcutaneous Electrical Nerve Stimulator for Pain. The WellnessPro 2010 Plus is designed to provide electrical stimulation, for relief of chronic, intractable pain and as an adjunctive treatment of post-surgical or port-traumatic acute pain, in a single compact, lightweight user friendly package.
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
- 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 |
|---|---|---|---|---|
| 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 | B243SSWP2010PLUS0 | HIBCC |
Customer Contacts
- Phone
- 1-888-880-7888
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062616 | 000 |