FDA UDI
In Commercial Distribution
🇺🇸 United States
Xavant Technology
DI: 06009880396245
·
Model: STIMPOD NMS460 KIT
·
XAVANT TECHNOLOGY (PTY) LTD
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Xavant Technology
- Primary DI
- 06009880396245
- Version / Model
- STIMPOD NMS460 KIT
- Catalog Number
- XT-46001
- Company Name
- XAVANT TECHNOLOGY (PTY) LTD
- Labeler DUNS
- 639571707
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-23
- Public Version
- 4
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 65124290-f377-4115-a410-8ca1c0caabf9
Device Description
The STIMPOD NMS460 is a Low Frequency Neuromodulation Transcutaneous Electrical Nerve Stimulation device, used for symptomatic relief and management of chronic intractable pain and/or as and adjunctive treatment in the management of post-surgical pain, post traumatic acute pain, as well as and adjunct for pain control due to rehabilitation. The STIMPOD NMS460 offers two types of waveforms for the treatment of pain. The first is a Monophasic Square Wave, which is typical of normal TENS machines. The second waveform is a Hybrid RF waveform which consists of a Monophasic Square Wave with a superimposed Radio Frequency waveform. This waveform is proprietary and is unique to the STIMPOD NMS460.
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 |
|---|---|---|---|---|---|---|
| Package | 46009880396243 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 36009880396246 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 26009880396249 | GS1 | Box | 5 | In Commercial Distribution | |
| Package | 16009880396242 | GS1 | Carry Case | 1 | In Commercial Distribution | |
| Primary | 06009880396245 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161091 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- – 90 Percent (%) Relative Humidity