MalfunctionISA
CAVITATION RF SLIMMING SYSTEM ZIRRA BY ZEMITS
Received Apr 9, 2019 · Event occurred Apr 1, 2019
Report MW5085721 · MDR key 8500051
Device
Generic name
Massager, Therapeutic, Electric
Manufacturer
Advance - Esthetic LlcModel number
HTTP://ADVANCE-ESTHETIC.US/CAVProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
56 YR
- Burn, Thermal
- Burn, Thermal
Narrative
Description of Event or Problem
HAD A TREATMENT WITH THE RF CAVITATION TENS POWERED STIMULATORS MACHINES AND WAS BURNED. ALL THESE MACHINES REQUIRE FDA 510K CLEARANCE AND THEY IMPORT FROM (B)(4) AND DO NOT HAVE ANY FDA 510K APPROVALS. PLEASE SHUT THIS COMPANY DOWN: ESTABLISHMENT: (B)(6), (B)(4), STATUS: ACTIVE, DATE OF REGISTRATION STATUS: 2019; OWNER/OPERATOR: (B)(6), OWNER/OPERATOR NUMBER: (B)(4), OFFICIAL CORRESPONDENT: (B)(6), PHONE: (B)(6). (B)(6). FDA SAFETY REPORT ID# (B)(4).