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510(k) K903017

MEGA-TENS DUAL CHANNEL T.E.N.S. by Futuremed Div. of Future Impex Corp. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1990
Date Received
July 10, 1990
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 Futuremed Div. of Future Impex Corp.

  • K933511 — UPGRADED SPIROMETER ST-90 (February 10, 1994)
  • K933220 — SELECTOR SL 01 (November 24, 1993)
  • K933222 — AUDIOMETER DA 323 (November 1, 1993)
  • K901308 — SPIRO ANALYZER MODEL ST 250 (July 23, 1990)
  • K884972 — TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR (July 27, 1989)
  • K871421 — MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT (January 22, 1988)
  • K873817 — SPIRO ANALYZER ST-300 (December 2, 1987)
  • K872044 — CARBON ELECTRODE (July 16, 1987)
  • K872045 — CONDUCTIVITY GEL (July 15, 1987)
  • K871913 — CONDUCTIVITY GEL (July 15, 1987)

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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)