Xavant Technology XT-46001A

GUDID 06009880396832

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.

XAVANT TECHNOLOGY (PTY) LTD

Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 06009880396832
• NIH Device Record Key: 41ae7f17-080d-4a98-95bf-e80a46d029f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xavant Technology
• Version Model Number: STIMPOD NMS460 Kit
• Catalog Number: XT-46001A
• Company DUNS: 639571707
• Company Name: XAVANT TECHNOLOGY (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	06009880396832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161091

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-12
• Device Publish Date: 2023-06-02

On-Brand Devices [Xavant Technology]

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• 46009880396335: Neuromuscular blocking agent monitoring cable (1.8 m) with three dimensional acceleromyography.
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• 46009880396311: The STIMPOD NMS 450 is a precision nerve locating tool used for localizing specific neural pathw
• 46009880396243: The STIMPOD NMS460 is a Low Frequency Neuromodulation Transcutaneous Electrical Nerve Stimulatio
• 06009880396160: Neuromuscular blocking agent monitoring cable (3.5 m) with three dimensional acceleromyography.
• 46009880396151: Neuromuscular blocking agent monitoring cable (1.5m) with three-dimensional acceleromyography.
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• 06009880396085: This cable is used to activate the Nerve Locating mode on the STIMPOD. The red (anode) connector
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• 06009880396030: Nerve mapping cable for NMS460.
• 06009880396023: The STIMPOD NMS415 is a precision nerve mapping tool used for localizing specific neural pathway
• 16009880396785: Quantitative NMT Monitor
• 06009880396832: The STIMPOD NMS460 is a Low Frequency Neuromodulation Transcutaneous Electrical Nerve Stimulatio
• 06009880396825: The STIMPOD NMS460 is a Low Frequency Neuromodulation Transcutaneous Electrical Nerve Stimulatio
• 06009880396870: The STIMPOD NMS450 is a Quantitative Neuromuscular Blockade monitor. The STIMPOD NMS 450 is als