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Empi

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
60
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K093324EMPI CONTINUUMMarch 5, 2010
K090922EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATORJune 5, 2009
K072946HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEMNovember 16, 2007
K070427DUPEL TRANSPORT IONTOPHORESIS SYSTEMMay 14, 2007
K061650SELECT TENS, MODEL 4600SJanuary 22, 2007
K041920INFINITY PLUS ELECTROTHERAPY SYSTEMJanuary 21, 2005
K042057INFINITY ELECTROTHERAPY SYSTEMDecember 17, 2004
K030395EMPI ACTION PATCH IONTOPHORESIS SYSTEMApril 8, 2003
K021100300 PV COMPLETE ELECTROTHERAPY SYSTEMJune 18, 2002
K991991DUPEL IONTOPHORESIS SYSTEMSeptember 10, 1999
K983484DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODEDecember 28, 1998
K983206SMALL VAGINAL/RECTAL ELECTRODENovember 3, 1998
K972054INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODEAugust 14, 1997
K971527INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEMJune 30, 1997
K970491DUPEL II BUFFERED IONTOPHORESIS ELECTRODESMay 30, 1997
K970307MINNOVA PELVIC FLOOR STIMULATION SYSTEMApril 22, 1997
K970203EPIX VTApril 14, 1997
K964577INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205)January 24, 1997
K951951FOCUS MODEL 795 UNITMay 17, 1996
K954272INNOVA RECTAL STIMULATON ELECTRODEApril 15, 1996