Home / 510(k) Clearances / K021100

510(k) K021100

300 PV COMPLETE ELECTROTHERAPY SYSTEM by Empi — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2002
Date Received
April 4, 2002
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

Other clearances by Empi

  • K093324 — EMPI CONTINUUM (March 5, 2010)
  • K090922 — EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR (June 5, 2009)
  • K072946 — HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM (November 16, 2007)
  • K070427 — DUPEL TRANSPORT IONTOPHORESIS SYSTEM (May 14, 2007)
  • 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)
  • K991991 — DUPEL IONTOPHORESIS SYSTEM (September 10, 1999)
  • K983484 — DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE (December 28, 1998)

Other clearances for product code IPF

  • K251083 — Compact II (September 12, 2025)
  • K241433 — EVE Synergy (EVE-20M) (June 4, 2025)
  • K241488 — TrainFES Advance (February 5, 2025)
  • K240348 — Quantum Mitohormesis (QMT) (M2101) (December 19, 2024)
  • K240992 — eMVFit (MVF-10M) (October 10, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)
  • K232786 — Stimulation System (PA series, PR series, S series and Q series) (May 16, 2024)
  • K233926 — accufit (March 21, 2024)
  • K233485 — M-Wave (January 26, 2024)