Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

Product Code: LPQ

Ultrasonic Medical Devices (Miscellaneous)

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

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

Code of Federal Regulations:


Radiation TypeAcoustic
Radition SafetyNone
Annual ReportsNo

Products Classified as LPQ

4712Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

Total Product Life Cycle (TPLC) Devices

4712Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

Pre-market Approvals for LPQ

P900009EXOGEN 2000/SONIC ACCELERATED FRACTURE HEALING SYSTEMBIOVENTUS LLC

Maude Adverse Events

SONICATOR 740XMETTLER ELECTRONICS CORP.2015-06-05
EXOGEN 4000 SYSTEMBIOVENTUS2014-05-28
BIOVENTUS EXOGEN 4000+ SYSTEMBIOVENTUS,LLC2013-08-29
SAFHS 2000 MOU ASSEMBLYBIOVENTUS LLC2013-07-25
EXOGEN 4000+ SYSTEM EXPORTBIOVENTUS LLC2013-05-28
EXOGENSMITH & NEPHEW, INC.2012-05-08
EXOGENSMITH & NEPHEW ORTHOPAEDICS, INC.2012-04-03
EXOGEN 4000SMITH & NEPHEW ORTHOPAEDICS, INC.2012-03-21
EXOGEN 4000SMITH & NEPHEW ORTHOPAEDICS2012-02-24
SAFHS 2000 MOU ASSEMBLYSMITH & NEPHEW ORTHOPAEDICS2011-12-13
EXOGEN 4000+SMITH & NEPHEW ORTHOPAEDICS2011-11-04
EXOGENSMITH & NEPHEW, ORTHOPEDICS2011-05-06
EXOGENSMITH & NEPHEW ORTHOPAEDICS2011-03-16
EXOGENBROOKS MANUFACTURING SITE2010-03-18
LEXOS DR-TBIOTRONIK GMBH AND CO.2008-03-28
EXOGEN COUPLING GELSMITH & NEPHEW, INC., ORTHOPAEDIC DIV.2008-02-29
EXCEL*2002-12-14
EXOGEN ULTRASOUND HEALING SYSTEMEXOGEN, INC.1999-03-08
SAFHS SONIC ACCELERATED FRACTURE HEALING SYSTEMEXOGEN, INC.1996-04-15
SAFHS SONIC ACCELERATED FRACTURE HEALING SYSTEMEXOGEN, INC.1996-04-15
SAFHS SONIC ACCELERATED FRACTURE HEALING SYSTEMEXOGEN, INC.1996-04-15
SAFHSEXOGEN, INC.1995-09-27
SAFHSEXOGEN, INC.1995-08-17
SAFHSEXOGEN, INC.1995-07-19
SAFHSEXOGEN, INC.1995-07-19
TREATMENT HEAD MODULEEXOGEN,INC.1995-05-11
TREATMENT HEAD MODULEEXOGEN, INC.1995-05-05
SAFHS SONIC ACCELERATED FRACTURE HEALING SYSTEMEXOGEN, INC.1995-02-28
DYNATRONDYNATRONICS1994-08-29

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