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510(k) Data Aggregation
K Number
K234036Device Name
SONIK MONARK 100
Manufacturer
Neuro Spinal Innovation Inc
Date Cleared
2024-02-15
(56 days)
Product Code
LXM
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Neuro Spinal Innovation Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SONIK MONARK 100 device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the device to deliver precise impulses at a required vector configuration.
Device Description
The SONIK MONARK 100 (SM-100) device is used for the management of chronic pain due to noncongenital defects. It operates through the delivery of low-frequency impulses onto intact skin. The device converts electrical energy into mechanical energy, which is then transmitted to the patient's tissues through the stylus tip. It employs a mode of action that involves the application of controlled and repeatable low-intensity mechanical impulses to the treatment site. The device can be used in a handheld manner or mounted to a movable arm on a cart.
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