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510(k) Data Aggregation
K Number
K050428Device Name
TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)
Manufacturer
ADVANCED SPINAL TECHNOLOGIES, INC.
Date Cleared
2005-06-14
(116 days)
Product Code
LXM
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ADVANCED SPINAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Advanced Spinal Mobilization Instrument (ASMI) is for adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine by a licensed health care professional. The device is for external use only.
Device Description
The Advanced Spinal Mobilization Instrument (ASMI) is a handheld electromechanical device intended for adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine by a licensed health care professional. The device operates in three distinct modes: introductory, mobilization, and recovery. The system incorporates a handset connected to a console. The handset consists of a metal body containing pistons and two five-port solenoid-operated valves. The console consists of a filter/regulator/filter (FRF) and a metal case which contains a proportional valve and printed circuit board (PCB). The pads, the only patient contact part, are made of silicon. The system is designed for standard connection to a compressed air source. The equipment is failsafe. The power supply is via a transformer with an output of 1.7 A at 12V. In recovery mode, the ASMI transmits a peak force of 50N. In mobilization mode, the pistons act as air springs or cushions and therefore primarily transmit the mobilizing effort applied by the practitioner.
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