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510(k) K041920

INFINITY PLUS ELECTROTHERAPY SYSTEM by Empi — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2005
Date Received
July 16, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

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  • K061650 — SELECT TENS, MODEL 4600S (January 22, 2007)
  • K042057 — INFINITY ELECTROTHERAPY SYSTEM (December 17, 2004)
  • K030395 — EMPI ACTION PATCH IONTOPHORESIS SYSTEM (April 8, 2003)
  • K021100 — 300 PV COMPLETE ELECTROTHERAPY SYSTEM (June 18, 2002)
  • K991991 — DUPEL IONTOPHORESIS SYSTEM (September 10, 1999)
  • K983484 — DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE (December 28, 1998)

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