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510(k) Data Aggregation
K Number
K133108Device Name
FIT BELT
Manufacturer
Date Cleared
2014-08-05
(309 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
HONG QIANG XING (SHENZHEN) ELECTRONICS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SM9065 Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.
- The big belt is intended for use on the muscles in abdomen.
- The small belt is intended for use on the muscles in arms and thighs areas.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
Device Description
SM9065 Fitness Belt is a two channels battery operated muscle stimulation system to achieve the purpose of exercise and relaxation. It is comprised of a main device for signal generation, four belts for fixation, and series electrodes.
The big belt is intended for use on muscles in abdomen. The two small belts are intended for use on muscles in arms and thigh areas.
Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level and frequency level can be adjusted by user.
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