FDA UDI
In Commercial Distribution
🇺🇸 United States
NSS NeuroStim
DI: B960NSS201
·
Model: NeuroStim
·
Neuraxis, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
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Basic Information
- Brand Name
- NSS NeuroStim
- Primary DI
- B960NSS201
- Version / Model
- NeuroStim
- Catalog Number
- 01-1021
- Company Name
- Neuraxis, Inc.
- Labeler DUNS
- 063076701
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-09
- Public Version
- 6
- Public Version Date
- 2024-02-06
- Public Version Status
- Update
- Public Device Record Key
- 55eafbce-0859-4651-8551-91be6497340b
Device Description
The NSS Neurostim ((510K-140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS Neurostim is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The NSS Neurostim is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS Neurostim offers regular therapy over several days. The appliance transmits low frequency electric pulses to exposed nerve endings.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BWK | Stimulator, Electro-Acupuncture | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13763 | Acupuncture electrical stimulation system | An electrically-powered unit designed to be used specifically to apply electrical stimuli to acupuncture sites (electroacupuncture). It is an external low-intensity, low frequency pulse (usually 1 to 100 pulses per second), multimode generator intended to connect to acupuncture electrodes. The electrodes may be placed either on the skin, or through acupuncture needles that penetrate the skin at the acupuncture points. Some may use a probe to detect the acupuncture sites using visual or audio signals. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B960NSS201 | HIBCC | ||||
| Package | B960NSS2011 | HIBCC | Box | 10 | In Commercial Distribution | |
| Package | B960NSS2012 | HIBCC | Box | 20 | In Commercial Distribution | |
| Previous | B327NSS201 | HIBCC | ||||
| Package | B960NSS2013 | HIBCC | Box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 8126890791
- [email protected]