AccessGUDID - DEVICE: Prosoft GT (00086001141645)

GUDID

Device Identifier (DI) Information

Brand Name: Prosoft GT
Version or Model: Prosoft GT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Neuromechanical Innovations, L.L.C.

Primary DI Number: 00086001141645
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 806724360 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58785	Joint/spinal manipulator, electronic	A hand-held, electrically-powered instrument intended to be used by a healthcare professional for the chiropractic adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. The electromechanical instrument is typically pistol-like in shape and uses a plunger-like mechanism to deliver thrust to the patient's body with a single or double rubber-tipped stylus; it typically has several force settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXM	Manipulator, Plunger-Like Joint

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023462	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d1eaa381-be04-482e-a8d0-c9998345c41f
Public Version Date: January 22, 2024
Public Version Number: 1
DI Record Publish Date: January 13, 2024