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.

Joint/spinal manipulator, electronic

• Primary Device ID: 00086001141645
• NIH Device Record Key: d1eaa381-be04-482e-a8d0-c9998345c41f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prosoft GT
• Version Model Number: Prosoft GT
• Company DUNS: 806724360
• Company Name: Neuromechanical Innovations, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00086001141645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023462

FDA Product Code

• LXM: Manipulator, Plunger-Like Joint

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-22
• Device Publish Date: 2024-01-13

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

• 00860011416487 - Prosoft SRT: 2024-02-16 Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobil
• 00086001141645 - Prosoft GT: 2024-01-22Chiropractic 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 GT: 2024-01-22 Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobil
• 00860011416401 - Impulse Adjusting Instrument: 2024-01-22 Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobil
• 00860011416418 - Impulse iQ Adjusting Instrument: 2024-01-22 Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobil
• 00860011416463 - Prosports 360: 2024-01-22 Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobil
• 00860011416470 - ProAdjuster SRT: 2024-01-22 Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobil