FDA UDI
In Commercial Distribution
🇺🇸 United States
NeMa-st - soleve
DI: 07290019787013
·
Model: 3.3
·
LIGHTRAY-PLUS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NeMa-st - soleve
- Primary DI
- 07290019787013
- Version / Model
- 3.3
- Catalog Number
- 08-810-00000
- Company Name
- LIGHTRAY-PLUS LTD
- Labeler DUNS
- 521166280
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-20
- Public Version
- 1
- Public Version Date
- 2023-11-28
- Public Version Status
- New
- Public Device Record Key
- b28f5806-18f1-4adc-8770-9ccdbe67c1e2
Device Description
The NeMa-st - Soleve device is intended for Transcutaneous Electrical nerve Stimulation for back pain relief. NeMa-st - Soleve is indicated for the relief and management of symptomatic chronic or intractable back pain and/or post-surgical back pain and/or post trauma back pain. Soleve is designed to deliver electrical stimulation using small contact surface probes. It includes an array of 26 probes connected to a motion system, enabling the provision of electrical stimulation to multiple points in the back.
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
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 07290019787013 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100668 | 000 |