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510(k) K874085

REBUILDER(TM) by Micromed, Inc. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1987
Date Received
October 7, 1987
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 Micromed, Inc.

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  • K071782 — MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES (January 10, 2008)
  • K914762 — MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR (December 5, 1991)
  • K882980 — REBUILDER BUCKET SYSTEM (April 24, 1989)

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  • 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)