Massager, Vacuum, Radio Frequency Induced Heat

Product Code: PBX

General & Plastic Surgery Microwave Diathermy Machines

Definition: Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4400


Radiation TypeMicrowave EMF
Radition SafetyNone
Annual ReportsNo

Products Classified as PBX

5857Massager, Vacuum, Radio Frequency Induced HeatElectrosurgical Cutting And Coagulation Device And Accessories.

Total Product Life Cycle (TPLC) Devices

5857Massager, Vacuum, Radio Frequency Induced HeatElectrosurgical Cutting And Coagulation Device And Accessories.

Pre-market Notifications for PBX

K220592Venus BlissMAXVenus Concept USA Inc.
K213308Venus BlissMAXVenus Concept USA Inc.
K213295C.C. LIFE 2121 Equipment S.R.L.
K212253Apollo Duet (Model : APD-4000)Weero Co.
K211461Family Of Venus RF Systems - Venus FreedomVenus Concept USA Inc.
K211091Deka Tiac IIEL.EN Electronic Engineering Spa
K210877Evolve System With The T3 ApplicatorInMode Ltd.
K210867NuEra Tight RF, NuEra Tight RF PlusBIOS S.r.l.
K202780SectumNeauvia North America
K202247V30 System, V20 System, V10 System, V-VR Hand PieceViora Ltd.
K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.
K201064V30 System, V20 System, V10 System, V-FR HandpieceViora Ltd.
K200468V30 System, V20 System, V10 System, V-FC HandpieceViora Ltd.
K200241TempSure SystemCynosure LLC
K191855EmFace DeviceInMode MD Ltd.

Global Unique Device Identification Database

00816722022424Massager, Vacuum, Radio Frequency Induced Heat
00816722022417Massager, Vacuum, Radio Frequency Induced Heat
00816722022400Massager, Vacuum, Radio Frequency Induced Heat
00816722021403Massager, Vacuum, Radio Frequency Induced Heat
07290109952642Massager, Vacuum, Radio Frequency Induced Heat
07290016814088Massager, Vacuum, Radio Frequency Induced Heat
07290016746419Massager, Vacuum, Radio Frequency Induced Heat
07290016746280Massager, Vacuum, Radio Frequency Induced Heat
07290016746266Massager, Vacuum, Radio Frequency Induced Heat
07290016746006Massager, Vacuum, Radio Frequency Induced Heat
07290016681277Massager, Vacuum, Radio Frequency Induced Heat
07290016681000Massager, Vacuum, Radio Frequency Induced Heat
07290016541533Massager, Vacuum, Radio Frequency Induced Heat
07290016541472Massager, Vacuum, Radio Frequency Induced Heat
07290016541144Massager, Vacuum, Radio Frequency Induced Heat

Maude Adverse Events

NUERABIOS SRL2019-10-22
TRUSCULPT IDCUTERA, INC2019-04-22
TRUSCULPT IDCUTERA, INC2019-01-02
TRUSCULPT 3DCUTERA INC2018-09-05
TRUSCULPTCUTERA, INC2017-08-04
TRUSCULPTCUTERA, INC2016-07-12
THERMISMOOTHALMIRALL COMPANY2016-05-03
TRUSCULPTCUTERA, INC.2014-10-10
TRUSCULPTCUTERA, INC.2014-08-14
TRUSCULPTCUTERA, INC.2014-08-14
TRUSCULPTCUTERA2014-06-04
TRUSCULPTCUTERA2014-04-09
TRUSCULPTCUTERA2013-10-29
TRUSCULPTCUTERA, INC.2013-09-24
TRUSCULPTCUTERA, INC.2013-08-20
TRUSCCULPTCUTERA, INC.2013-08-20
TRUSCULPTCUTERA, INC.2013-08-05
TRUSCULPTCUTERA, INC.2013-08-05
TRUSCULPTCUTERA, INC.2013-07-09
TRUSCULPTCUTERA, INC.2013-07-02
TRUSCULPTCUTERA, INC.2013-07-02
TRUSCULPTCUTERA, INC.2013-02-26
TRUSCULPTCUTERA, INC.2013-01-11
TRUSCULPTCUTERA, INC.2013-01-11
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