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510(k) Data Aggregation
K Number
K130052Device Name
TONE-A-MATIC
Manufacturer
Date Cleared
2013-12-20
(345 days)
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
TONE-A-MATIC INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Tone-A-Matic is indicated to be used for
- · Russian and EMS for:
- o Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy o
- Increase local blood circulation o
- Muscle re-education o
- Maintaining or increasing range of motion o
- Immediate postsurgical stimulation of calf muscles to prevent venous 0 thrombosis.
- TENS for: ●
- Symptomatic relief of chronic, intractable pain. o
- o Management of pain associated with post-traumatic or post-operative conditions.
Device Description
The Tone-A-Matic is a Tone-A-Matic Device is Non-TRANSIT-OPERABLE and PORTABLE micro-controller operated device not to be Worn by patient. It generates electrical impulses and effectively transfers your desired choice of these pre-programmed electrical impulses directly through the electrode adhesive pads to the suggested area of the body where the electrodes are placed. Tone-A-Matic was developed based on physics, electro biology and modern micro-electronic technology. You will be more than pleased with this state-of-the-art device.
The Tone-A-Matic is very user friendly with a large liguid crystal display (LCD) screen that displays the treatment mode in use, a countdown timer and battery indicator. The intensity of the treatment can be increased or decreased by Keypads. User can set the time of the treatment from available choice of 1 min. to 60 min.
It is a clinical model with easy user interface and versatility to treat different body areas simultaneously. This aesthetically designed clinical model has 3 selectable modes(Russian, TENS, EMS) and treatment parameters. The state of the art Tone-A-Matic is light weight (1.78 Kg), small in size (10.3" X 7.5" X 3.5", LxWxH) and battery powered which allows it to be easily moved to any location for immediate use.
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