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Substantial Equivalence The submitted Mini E012-O1 is constructed to perform like the predicate Slendertone 56 1. HEALTH CARE EQUIPMENT CO. LTD. K Number K071666 Mini Model EC1201 K070612 Accessory Electrodes to Proposed Indications The proposed indications for the predicate Slendertone 561 and the submitted Mini EC12-01 are the same. Fda. ov/MedicalDevices/Safety/ReportaProblem/defhtult.hiti for the CDRH s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 4 x 4. 7...
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