NSS Neurostim 01-1021

GUDID B327NSS201

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.

KEY ELECTRONICS, INC.

Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system
Primary Device IDB327NSS201
NIH Device Record Key62429bc6-efb1-489f-8e7a-3ea6a82244d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameNSS Neurostim
Version Model NumberNeurostim
Catalog Number01-1021
Company DUNS172218799
Company NameKEY ELECTRONICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB327NSS201 [Primary]
HIBCCB327NSS2011 [Package]
Package: BOX [10 Units]
In Commercial Distribution
HIBCCB327NSS2012 [Package]
Package: BOX [20 Units]
In Commercial Distribution

FDA Product Code

BWKStimulator, Electro-Acupuncture

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
Device Publish Date2019-03-22

Devices Manufactured by KEY ELECTRONICS, INC.

B327NSS201 - NSS Neurostim2019-10-23The 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.
B327NSS201 - NSS Neurostim2019-10-23 The NSS Neurostim ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of
B327NSS202 - NSS MFS2019-10-23 The NSS Military Field Stimulator (MFS) ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in
B327NSS2032 - IB-STIM2019-10-07 The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population
B327NSS200 - NSS-22019-10-07 The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of op
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