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510(k) K163150

ViMove2 by Dorsavi, Ltd. — Product Code IKN

K163150 is an FDA 510(k) premarket notification submitted by Dorsavi, Ltd. for the device "ViMove2". The FDA issued a decision of Substantially Equivalent on July 14, 2017. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375. Dorsavi, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2017
Date Received
November 9, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromyograph, Diagnostic
Device Class
Class II
Regulation Number
890.1375
Review Panel
NE
Submission Type

Other clearances by Dorsavi, Ltd.

  • K142494 — ViMove (May 28, 2015)

Other clearances for product code IKN

  • K172743 — Natus VikingQuest (December 19, 2017)
  • K162383 — Cadwell Sierra Summit, Cadwell Sierra Ascent (March 1, 2017)
  • K142494 — ViMove (May 28, 2015)
  • K131094 — VIMOVE (July 11, 2014)
  • K123902 — PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) (September 13, 2013)
  • K123399 — MYOVISION 3.0 WIREFREE SYSTEM (August 1, 2013)
  • K113074 — CMAP PRO (February 2, 2012)
  • K102610 — FOCUS EMG DEVICE (March 4, 2011)
  • K110048 — CERSR ELECTROMYOGRAPHY SYSTEM (January 26, 2011)
  • K083679 — UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 (September 11, 2009)

FDA data resources