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

• Primary Device ID: B327NSS201
• NIH Device Record Key: 62429bc6-efb1-489f-8e7a-3ea6a82244d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NSS Neurostim
• Version Model Number: Neurostim
• Catalog Number: 01-1021
• Company DUNS: 172218799
• Company Name: KEY ELECTRONICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B327NSS201 [Primary]
HIBCC	B327NSS2011 [Package]; Package: BOX [10 Units]; In Commercial Distribution
HIBCC	B327NSS2012 [Package]; Package: BOX [20 Units]; In Commercial Distribution

FDA Product Code

• BWK: Stimulator, Electro-Acupuncture

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-03-22

Devices Manufactured by KEY ELECTRONICS, INC.

• B327NSS201 - NSS Neurostim: 2019-10-23The 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 Neurostim: 2019-10-23 The NSS Neurostim ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of
• B327NSS202 - NSS MFS: 2019-10-23 The NSS Military Field Stimulator (MFS) ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in
• B327NSS2032 - IB-STIM: 2019-10-07 The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population
• B327NSS200 - NSS-2: 2019-10-07 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