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510(k) K011543

TENS CARE, MODEL XL-Y3 by Tenscare, Ltd. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2001
Date Received
May 18, 2001
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 Tenscare, Ltd.

  • K232441 — Unipro (K-UNIPRO-US) (August 30, 2024)
  • K230926 — Ova+ (K-OVAP-USA) (December 15, 2023)
  • K230983 — Unicare (K-UNICARE-USA) (October 20, 2023)
  • K231053 — Unicare (K-UNICARE-USA) (August 18, 2023)
  • K200694 — Perfect EMS (June 4, 2021)
  • K191312 — Perfect PFE (November 1, 2019)
  • K142506 — TensCare KegelFit (April 20, 2015)
  • K103698 — TENSCARE ITOUCH SURE MODEL ITS (June 21, 2011)
  • K082377 — TENSCARE ITOUCH MODEL(S) EASY AND PLUS (February 9, 2009)
  • K023997 — TENSCARE ULTIMA NMS/EMS (March 3, 2003)

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)