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510(k) K120054

ULTIMA NEO by Pain Management Technologies — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2012
Date Received
January 6, 2012
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

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  • K030375 — SOFT-TOUCH TENS ELECTRODE (May 5, 2003)
  • K011411 — SELF-ADHESIVE ELECTRODES (June 13, 2001)

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