Xavant Technology - The STIMPOD NMS460 is a Low Frequency - XAVANT TECHNOLOGY (PTY) LTD

Duns Number:639571707

Device Description: The STIMPOD NMS460 is a Low Frequency Neuromodulation Transcutaneous Electrical Nerve Stim 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.

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More Product Details

Catalog Number

XT-46001

Brand Name

Xavant Technology

Version/Model Number

STIMPOD NMS460 KIT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

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

K161091,K161091,K161091,K161091,K161091

Product Code Details

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Device Record Status

Public Device Record Key

65124290-f377-4115-a410-8ca1c0caabf9

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

March 23, 2017

Additional Identifiers

Package DI Number

46009880396243

Quantity per Package

2

Contains DI Package

36009880396246

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"XAVANT TECHNOLOGY (PTY) LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3