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510(k) K093324

EMPI CONTINUUM by Empi — Product Code IPF

K093324 is an FDA 510(k) premarket notification submitted by Empi for the device "EMPI CONTINUUM". The FDA issued a decision of Substantially Equivalent on March 5, 2010. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Empi has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2010
Date Received
October 23, 2009
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

  • 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)
  • 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)

Other clearances for product code IPF

  • K253542 — Apollo Quattro (APQ-10M) (June 8, 2026)
  • K252816 — High Tone Power therapy (HiToP) (Model: HiToP PNP) (June 2, 2026)
  • K260142 — StimelMD (SSMD) system (May 27, 2026)
  • 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)

FDA data resources