FDA.reportPublic FDA data

510(k) K240788

Device
Ultrasound Stimulator
Applicant
Jkh Health Co., Ltd.
510(k) number
K240788
Product code
IMI
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-04
Date received
2024-03-22
Regulation
890.5300
Classification name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Pu Jiang
Address
4-5f, Bldg. 12, Hengmingzhu Industrial Park Xinqiao Tongfuyu Industrial Area, Shajing, Baoan Shenzhen CN 518104 518104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IMI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230472Sonopuls 190Enraf-Nonius, B.V.2023-10-24
K222098ManaSport+Manamed, Inc.2023-03-08
K210284ManaSportManamed, Inc.2022-04-26
K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E Orto2021-12-23
K160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd.2017-08-25
K161628JAS Pulse(TM) Ultrasonic TherapyBonutti Research, Inc.2016-11-10
K160075Accent XLAlma Lasers, Inc.2016-08-17
K161502MC1 PlusGeneral Project S.R.L.2016-08-16
K142976UltraTENSShenzhen Dongdixin Technology Co., Ltd.2015-08-26
K131309SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZIbramed Equipamentos Medicos2014-01-27
K130888SONOPULSE/ SONOPULSE IIIIbramed- Industria Brazileria DE Equipamentos Medi2014-01-09
K124010ACCUSONIC ADVANTAGEMetron Medical Australia, Pty, Ltd.2013-08-23
K120171ACCUSONIC ADVANTAGEMetron Medical Australia, Pty, Ltd.2012-05-04
K112520US-101L, US-103SIto Co., Ltd.2011-10-26
K091615MED CONTOURGeneral Project S.R.L.2010-05-06