Impulse Adjusting Instrument

Basic Information

• Brand Name: Impulse Adjusting Instrument
• Primary DI: 00860011416401
• Version / Model: Original Impulse
• Company Name: Neuromechanical Innovations, L.L.C.
• Labeler DUNS: 806724360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-13
• Public Version: 1
• Public Version Date: 2024-01-22
• Public Version Status: New
• Public Device Record Key: c927f5b4-44fa-4bbf-b89e-ab151c1e45ec

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

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXM	Manipulator, Plunger-Like Joint	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860011416401	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K023462	000