Activator Methods

Basic Information

• Brand Name: Activator Methods
• Primary DI: 00850021303136
• Version / Model: ARIV Dark Blue
• Company Name: Activator Methods International, Ltd.
• Labeler DUNS: 194879383
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-16
• Public Version: 1
• Public Version Date: 2020-10-26
• Public Version Status: New
• Public Device Record Key: 332f9d20-f4a5-4cf6-8541-f723a15e5f22

Device Description

Chiropractic Adjusting Instrument

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: No
• 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
63426	Joint/spinal manipulator, mechanical	A hand-held, non-electric, mechanically-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 instrument uses a manually-operated, mechanical, plunger-like mechanism (e.g., spring-loaded) to deliver thrust to the patient's body via its rounded distal end (e.g., rubber-tipped stylus); it typically has two or more 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	00850021303136	GS1

Premarket Submissions

Submission Number	Supplement Number
K003185	000