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510(k) K230926

Ova+ (K-OVAP-USA) by Tenscare, Ltd. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2023
Date Received
April 3, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

Other clearances by Tenscare, Ltd.

  • K232441 — Unipro (K-UNIPRO-US) (August 30, 2024)
  • 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)
  • K020846 — ULTIMA TENS XL-A1 (May 21, 2002)

Other clearances for product code NUH

  • K253896 — TENS/EMS device (GUSE01) (March 4, 2026)
  • K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) (December 31, 2025)
  • K251958 — VEINOPLUS Back (December 23, 2025)
  • K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D) (December 23, 2025)
  • K252688 — Transcutaneous Electrical Nerve Stimulator (RJTENS-2) (November 24, 2025)
  • K251856 — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 (November 21, 2025)
  • K243131 — Triathlon Pro (November 7, 2025)
  • K251429 — OTC 4-Channel Rechargeable TENS Unit (August 28, 2025)
  • K250784 — Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ (August 21, 2025)
  • K251187 — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) (July 28, 2025)