Prosoft GT

GUDID 00086001141645

Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobilization of musculoskeletal joints that provides impulsive single and multiple thrusts over three selectable force settings.

Neuromechanical Innovations, L.L.C.

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Primary Device ID00086001141645
NIH Device Record Keyd1eaa381-be04-482e-a8d0-c9998345c41f
Commercial Distribution StatusIn Commercial Distribution
Brand NameProsoft GT
Version Model NumberProsoft GT
Company DUNS806724360
Company NameNeuromechanical Innovations, L.L.C.
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100086001141645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXMManipulator, Plunger-Like Joint

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-22
Device Publish Date2024-01-13

Devices Manufactured by Neuromechanical Innovations, L.L.C.

00860011416487 - Prosoft SRT2024-02-16 Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobil
00086001141645 - Prosoft GT2024-01-22Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobilization of musculoskeletal joints that provides impulsive single and multiple thrusts over three selectable force settings.
00086001141645 - Prosoft GT2024-01-22 Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobil
00860011416401 - Impulse Adjusting Instrument2024-01-22 Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobil
00860011416418 - Impulse iQ Adjusting Instrument2024-01-22 Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobil
00860011416463 - Prosports 3602024-01-22 Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobil
00860011416470 - ProAdjuster SRT2024-01-22 Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobil
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