Home / 510(k) Clearances / K240788

510(k) K240788

Ultrasound Stimulator by Jkh Health Co., Ltd. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2025
Date Received
March 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

Other clearances by Jkh Health Co., Ltd.

  • K253150 — Cryon-X Cold Compression (October 24, 2025)
  • K240986 — Cold Compression (May 1, 2024)
  • K240011 — Lymphedema Compression (February 23, 2024)
  • K223541 — Cold/Hot Compression (October 27, 2023)
  • K211050 — Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 (November 28, 2022)
  • K202839 — Overlapped Compression Therapy (January 21, 2021)
  • K200561 — StimPlus Patch, StimPlus Patch, StimPlus Patch (July 1, 2020)
  • K162517 — Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 (April 14, 2017)
  • K153520 — Electronic Pulse Stimulator (May 5, 2016)

Other clearances for product code IMI

  • K230472 — Sonopuls 190 (October 24, 2023)
  • K222098 — ManaSport+ (March 8, 2023)
  • K210284 — ManaSport (April 26, 2022)
  • K202788 — Sonomed IV, Sonomed V (December 23, 2021)
  • K160378 — BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) (August 25, 2017)
  • K161628 — JAS Pulse(TM) Ultrasonic Therapy (November 10, 2016)
  • K160075 — Accent XL (August 17, 2016)
  • K161502 — MC1 Plus (August 16, 2016)
  • K142976 — UltraTENS (August 26, 2015)
  • K131309 — SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ (January 27, 2014)