Home / 510(k) Clearances / K023997

510(k) K023997

TENSCARE ULTIMA NMS/EMS by Tenscare, Ltd. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2003
Date Received
December 3, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
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)
  • K020846 — ULTIMA TENS XL-A1 (May 21, 2002)

Other clearances for product code IPF

  • K251083 — Compact II (September 12, 2025)
  • K241433 — EVE Synergy (EVE-20M) (June 4, 2025)
  • K241488 — TrainFES Advance (February 5, 2025)
  • K240348 — Quantum Mitohormesis (QMT) (M2101) (December 19, 2024)
  • K240992 — eMVFit (MVF-10M) (October 10, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)
  • K232786 — Stimulation System (PA series, PR series, S series and Q series) (May 16, 2024)
  • K233926 — accufit (March 21, 2024)
  • K233485 — M-Wave (January 26, 2024)