Home / 510(k) Clearances / K864114

510(k) K864114

TENS DEVICE FOR RELIEF OF CHRONIC PAIN by Futuremed Div. of Future Impex Corp. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1987
Date Received
October 21, 1986
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)
  • K903017 — MEGA-TENS DUAL CHANNEL T.E.N.S. (October 26, 1990)
  • 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)
  • K871913 — CONDUCTIVITY GEL (July 15, 1987)

Other clearances for product code GZJ

  • K252767 — actiTENS mini (January 16, 2026)
  • 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)