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510(k) K083494

ULTIMA FIVE by Pain Management Technologies — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2009
Date Received
November 25, 2008
Clearance Type
Traditional
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

Other clearances by Pain Management Technologies

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  • K120054 — ULTIMA NEO (June 5, 2012)
  • K073386 — JOINT STIM, MODEL 1000 (July 30, 2008)
  • K030375 — SOFT-TOUCH TENS ELECTRODE (May 5, 2003)
  • K011411 — SELF-ADHESIVE ELECTRODES (June 13, 2001)

Other clearances for product code GZJ

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  • K252236 — CP Relief Wand Rx - TENS/NMES (August 15, 2025)
  • K232441 — Unipro (K-UNIPRO-US) (August 30, 2024)
  • K241228 — TENSWave (August 27, 2024)
  • K233046 — Electrical Neuromuscular Stimulator, Cure Trio (April 19, 2024)
  • K222879 — Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (January 24, 2023)
  • K212618 — iRelieve Microcurrent Pain Relief System (September 14, 2022)
  • K213802 — StimOnTM Pain Relief System (GM2439) (August 26, 2022)
  • K220578 — Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) (May 25, 2022)
  • K220503 — TENS device-EmeTerm 2, Model: YF-ZTY-E2 (April 23, 2022)