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510(k) K063135

SONIC-STIM by Naimco, Inc. — Product Code IMG

K063135 is an FDA 510(k) premarket notification submitted by Naimco, Inc. for the device "SONIC-STIM". The FDA issued a decision of Substantially Equivalent on February 5, 2007. The device falls under product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5860. Naimco, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2007
Date Received
October 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5860
Review Panel
PM
Submission Type

Other clearances by Naimco, Inc.

  • K050469 — EZ-STIK ELECTRODES (May 13, 2005)
  • K040495 — NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 2 (April 22, 2004)

Other clearances for product code IMG

  • K244041 — Ultrasound Therapy Workstation (XMS-UET2) (October 7, 2025)
  • K153559 — OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy Sy (August 26, 2016)
  • K150436 — ComboRehab (November 13, 2015)
  • K150353 — BTL-4000 (November 13, 2015)
  • K120217 — SONICSTIMU COMBO THERAPEUTIC DEVICE (November 21, 2012)
  • K121059 — SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM (August 7, 2012)
  • K102524 — FUTURA (November 3, 2011)
  • K111482 — SONICATOR PLUS 920 (August 25, 2011)
  • K102190 — WINSTIM (March 17, 2011)
  • K092627 — CT2011 SONICSTIMU PAIN RELIEF DEVICE (January 14, 2010)

FDA data resources