Duns Number:172218799
Device Description: The NSS Neurostim ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, w The NSS Neurostim ((510)K140530) 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 weighing approximately 5 grams 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.
Catalog Number
01-1021
Brand Name
NSS Neurostim
Version/Model Number
Neurostim
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BWK
Product Code Name
Stimulator, Electro-Acupuncture
Public Device Record Key
62429bc6-efb1-489f-8e7a-3ea6a82244d8
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
March 22, 2019
Package DI Number
B327NSS2012
Quantity per Package
20
Contains DI Package
B327NSS201
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX