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510(k) K031995

COMPREHENSIVE NEUROMUSCULAR PROFILER by Medical Technologies Unlimited, Inc. — Product Code IKN

K031995 is an FDA 510(k) premarket notification submitted by Medical Technologies Unlimited, Inc. for the device "COMPREHENSIVE NEUROMUSCULAR PROFILER". The FDA issued a decision of Substantially Equivalent on January 7, 2004. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2004
Date Received
June 27, 2003
Clearance Type
Traditional
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

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  • 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)

FDA data resources