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510(k) K090922

EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR by Empi — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2009
Date Received
April 1, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Empi

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  • K061650 — SELECT TENS, MODEL 4600S (January 22, 2007)
  • K041920 — INFINITY PLUS ELECTROTHERAPY SYSTEM (January 21, 2005)
  • 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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  • K220503 — TENS device-EmeTerm 2, Model: YF-ZTY-E2 (April 23, 2022)