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510(k) K954272

INNOVA RECTAL STIMULATON ELECTRODE by Empi — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1996
Date Received
September 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Device Class
Class II
Regulation Number
876.5320
Review Panel
GU
Submission Type

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  • K041920 — INFINITY PLUS ELECTROTHERAPY SYSTEM (January 21, 2005)
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  • 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)

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