Xavant Technology XT-46000A

GUDID 06009880396825

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
Primary Device ID06009880396825
NIH Device Record Keyc5ffd2f8-06b9-4f3d-b2ee-d489e89895b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameXavant Technology
Version Model NumberSTIMPOD NMS460
Catalog NumberXT-46000A
Company DUNS639571707
Company NameXAVANT TECHNOLOGY (PTY) LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS106009880396825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-20
Device Publish Date2023-11-11

On-Brand Devices [Xavant Technology]

76009880396367The STIMPOD NMS410 is a precision nerve locating tool used for localizing specific neural pathwa
46009880396342Neuromuscular blocking agent monitoring cable (3.5 m) with three dimensional acceleromyography.
46009880396335Neuromuscular blocking agent monitoring cable (1.8 m) with three dimensional acceleromyography.
36009880396321The STIMPOD NMS 450 is a precision nerve locating tool used for localizing specific neural pathw
46009880396311The STIMPOD NMS 450 is a precision nerve locating tool used for localizing specific neural pathw
46009880396243The STIMPOD NMS460 is a Low Frequency Neuromodulation Transcutaneous Electrical Nerve Stimulatio
06009880396160Neuromuscular blocking agent monitoring cable (3.5 m) with three dimensional acceleromyography.
46009880396151Neuromuscular blocking agent monitoring cable (1.5m) with three-dimensional acceleromyography.
46009880396144The STIMPOD NMS 450 is a precision nerve locating tool used for localizing specific neural pathw
46009880396137The STIMPOD NMS450 is a precision nerve locating tool used for localizing specific neural pathwa
06009880396085This cable is used to activate the Nerve Locating mode on the STIMPOD. The red (anode) connector
06009880396078The STIMPOD NMS 410 is a precision nerve locating tool used for localizing specific neural pathw
06009880396030Nerve mapping cable for NMS460.
06009880396023The STIMPOD NMS415 is a precision nerve mapping tool used for localizing specific neural pathway
16009880396785Quantitative NMT Monitor
06009880396832The STIMPOD NMS460 is a Low Frequency Neuromodulation Transcutaneous Electrical Nerve Stimulatio
06009880396825The STIMPOD NMS460 is a Low Frequency Neuromodulation Transcutaneous Electrical Nerve Stimulatio
06009880396870The STIMPOD NMS450 is a Quantitative Neuromuscular Blockade monitor. The STIMPOD NMS 450 is als

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