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Found 5 results
510(k) Data Aggregation
K Number
K092476Device Name
SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M
Manufacturer
SPORT-ELEC
Date Cleared
2010-05-07
(268 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
SPORT-ELEC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Body Control System 4M is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks 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
Body Control System "4M" is a 2 channel battery operated muscle stimulation system specifically designed to exercise the muscles, It comprises namely an electronic stimulator module which generates the required stimulation signals. Body Control System "4M" comprises 4 electrodes, which connects the signals from the stimulator to the skin. The product is supplied with a User's Guide and a carry case.
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K Number
K092142Device Name
SPORT-ELEC BODY CONTROL SYSTEM BS
Manufacturer
SPORT-ELEC
Date Cleared
2010-02-05
(205 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
SPORT-ELEC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Body Control System is indicated for the improvement of buttocks muscles tone, for strengthening of buttocks muscles.
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
Body Control System "BS" is a 2 channel battery operated muscle stimulation system specifically designed to exercise the buttocks' muscles, It comprises namely an electronic stimulator module which generates the required stimulation signals.
Body Control System "BS" comprises a short with integral electrodes, which connects the signals from the stimulator to the skin. The built-in electrodes are located on the inner surface of the accessories. The product is supplied with the cream VC 57B/53 - 148, a User's Guide and a carry case.
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K Number
K091865Device Name
SPORT-ELEC BODY CONTROL SYSTEM
Manufacturer
SPORT-ELEC
Date Cleared
2009-11-13
(147 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
SPORT-ELEC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Body Control System is indicated for the improvement of arms and thighs muscles tone, for strengthening of arms and thighs muscles.
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
Body Control System is a 2 channel battery operated muscle stimulation system specifically designed to exercise the arms and thighs muscles, It comprises namely an electronic stimulator module which generates the required stimulation signals.
Body Control System comprises accessories with integral electrodes, which connects the signals from the stimulator to the skin. The built-in electrodes are located on the inner surface of the accessories.
The product is supplied with the cream VC 57B/53 -148, a User's Guide and a carry case.
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K Number
K081026Device Name
BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5
Manufacturer
SPORT-ELEC S.A.
Date Cleared
2008-11-05
(209 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
SPORT-ELEC S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Body Control is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal muscles.
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
Body Control is a 2 channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module which generates the required stimulation signals.
Body Control is comprised of a belt with integral electrodes, which connects the signals from the stimulator to the skin. The built-in electrodes are located on the inner surface of the belts. The product is supplied with the cream VC 57B/53 -148, a User's Guide and a carry case.
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K Number
K061914Device Name
SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS
Manufacturer
SPORT-ELEC S.A.
Date Cleared
2007-07-26
(385 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
SPORT-ELEC S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CT5 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen
Device Description
CT5 is a 2 channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It comprises namely an electronic stimulator module which generates the required stimulation signals.
CT5 comprises belt with integral electrodes, which connects the signals from the stimulator to the skin. The built-in electrodes are located on the inner surface of the belt, which take the place of the lead wires.
The product is supplied with the cream VC 57B/53 -148, a User's Guide and a carry case.
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