FDA.reportPublic FDA data

mTrigger

Primary DI
00863712000337
Brand
mTrigger
Company
MTRIGGER, LLC
Model
BI2612/BK2613
Device description
mTrigger Biofeedback System
Published
2019-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863712000337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863712000337008637120003378637120003370863712000337

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/interactive rehabilitation systemA computerized device assembly designed for: 1) analysis of biomechanical/neuromuscular function using dedicated hardware; and 2) neuromuscular rehabilitation therapy at multiple anatomical sites based on patient interaction with dedicated physical-response measuring hardware (e.g., dynamometer, standing force plates, EMG electrodes) providing feedback in a videogame-like format. It includes multiple pieces of neuromuscular function analysis and physical-response measuring hardware, computer interface devices and dedicated software; it is intended to be used with an off-the-shelf computer. It is not based on tracking movement through space (i.e., not a virtual-display rehabilitation system).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
302-502-7262info@mtrigger.com

Regulatory Flags#

DUNS number
080226941
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863712000306mTriggerAE24032018-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G345SL2000CIONICCionic, Inc.HCC2026-06-04
04560340091435Medical HAL Lower Limb TypeCYBERDYNE, INC.HCC2026-04-22
04560340091749Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091756Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091763Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
06970670070334XFTShenzhen XFT Medical LimitedHCC2026-04-14
00816271020377NoraxonNoraxon U.S.A., Inc.HCC2026-03-30
00816271020407UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020414UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020421UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020438UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020445UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020452UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020469UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020476UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020483UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020490UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020506UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020513UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020520UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020735CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020766UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020773CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020889Ultium / CoreNoraxon U.S.A., Inc.HCC2026-03-30