FDA.reportPublic FDA data

Xavant Technology

Primary DI
06009880396030
Brand
Xavant Technology
Company
XAVANT TECHNOLOGY (PTY) LTD
Model
Nerve mapping cable
Catalog number
XT-46003
Device description
Nerve mapping cable for NMS460.
Published
2017-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161091000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161091000STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd.2017-01-18GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16009880396037PackageGS11In Commercial Distribution
26009880396034PackageGS15In Commercial Distribution
36009880396031PackageGS12In Commercial Distribution
46009880396038PackageGS12In Commercial Distribution
06009880396030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1600988039603716009880396037
2600988039603426009880396034
3600988039603136009880396031
4600988039603846009880396038
06009880396030060098803960306009880396030

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
639571707
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06009880396085Xavant TechnologyNerve Locate CableXT-410032017-01-25
06009880396245Xavant TechnologySTIMPOD NMS460 KITXT-460012017-03-23
06009880396825Xavant TechnologySTIMPOD NMS460XT-46000A2023-11-11
06009880396832Xavant TechnologySTIMPOD NMS460 KitXT-46001A2023-06-02
06009880396184BIONESSSTIMPOD ST2-3000 KITST2-30002025-02-17
06009880396443BIOVENTUSSTIMPOD ST2-4010ST2-40102025-07-30
06009880396610STIMPOD X-LINKXT-45300XT-453002025-07-30
06009880396191BIONESSSTIMPOD ST2-3100 Stimulation Adapter CableST2-31002025-02-17
06009880396177STIMPODNMT Monitoring Cable EMG (3.0m)XT-45003B2024-11-15
06009880396429STIMPODNMT Monitoring Cable AMG (3.0m)XT-45025B2024-11-15
06009880396870Xavant TechnologySTIMPOD NMS450 KitXT-450302023-12-23
06009880396573STIMPODEMG Electrode LargeXT-45009L2022-12-08
06009880396696STIMPODNMT Monitoring Cable EMG (3.5m)XT45003A2022-11-19
06009880396689STIMPODNMT Monitoring Cable EMG (1.8m)XT450032022-11-18
16009880396693STIMPODNMT Monitoring Cable EMG (3.5m)XT45003A2022-11-19
06009880396788Xavant TechnologySTIMPOD NMS450 AMG Only Kit (1.8m)XT-45021D2021-08-18
16009880396785Xavant TechnologySTIMPOD NMS450 AMG Only Kit (1.8m)XT-45021D2021-08-18
46009880396243Xavant TechnologySTIMPOD NMS460 KITXT-460012017-03-23
06009880396368Xavant TechnologySTIMPOD NMS410 KitXT-410112018-11-02
76009880396367Xavant TechnologySTIMPOD NMS410 KitXT-410112018-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
00714905710024Fab StimDrive Devilbiss HealthcareGZJ2026-02-06
00810140062680RENPHOJoicom CorporationGZJ2025-10-20
00810140062697RENPHOJoicom CorporationGZJ2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.GZJ2025-10-03
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00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.GZJ2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.GZJ2025-09-11
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00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.GZJ2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.GZJ2025-08-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
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00661168000044Reliefband® Sport - Soft GreyRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000167Reliefband® 50 HoursRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000181Reliefband® Premier PlusRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00815290018303Therapist’s Choice® TENS 12MT Small Carrying CaseCLINICAL HEALTH SERVICES, INC.GZJ2024-12-21
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
00810113683218ManaMedManamed, Inc.GZJ2024-04-30
B786SBM1AB0110actiTENSSUBLIMEDGZJ2024-04-24
20192253018360Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
20192253018377Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
B731P12T109TrueReliefTruerelief, LLCGZJ2024-01-08
00815290019409ePower® T1 TENS UNITCLINICAL HEALTH SERVICES, INC.GZJ2023-09-17