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510(k) K965187

SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD by Sparta Surgical Corp. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1997
Date Received
December 24, 1996
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 Sparta Surgical Corp.

  • K945313 — SPARTA HYDROGEL WOUND DRESSING (January 12, 1995)
  • K922729 — SPARTA WET DRESSING, SODIUM CHLORIDE (November 23, 1992)
  • K905384 — DAVID SIMMONDS ANESTHESIA EXTENSION TUBES (March 22, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K896085 — SURGI-BRUSH (November 8, 1989)
  • K896084 — MICROSPEARS (November 2, 1989)

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)