Tri-Wave Combination Stimulator

The Elite Medical Supply of NY EMS100 Tri-Wave Combination Stimulator (the Device) is a battery and 110V wall adapter powered electrotherapy devices intended for clinic and outpatient…

Registry build 21.09.26

The Elite Medical Supply of NY EMS100 Tri-Wave Combination Stimulator (the Device) is a battery and 110V wall adapter powered electrotherapy devices intended for clinic and outpatient rehabilitative therapy, acute postoperative care and home use for patients suffering from a variety of chronic pain issues. Prescribed by a physician, it gives the clinician a variety of electrotherapy modes to treat a range of indications. The Device is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The Intended Use Environment is Home Healthcare but the Device can also be used in a Chiropractic, Physical Therapy or Pain Management Clinic. The Device uses a tactile button user interface for control of the operating system and therapy amplitude settings. The Device has a liquid crystal character display which provides information to the user and displays the current therapy settings. The Device’s therapeutic output is transmitted through the patient lead wires to the cutaneous hydrogel electrodes affixed to the user’s skin. The energy generated by the Device is conveyed, via the patient lead wires and cutaneous electrodes, through the patients skin to excite either the underlying motor nerves to elicit involuntary muscle contractions or the sensory nerves to manage pain.

7manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (6), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LIH
Manufacturer City Province Registered as Device types
ATL Technology DG,Ltd. Dongguan Guangdong Contract manufacturer 14
Shenzhen Dongdixin Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
BIO Protech Yantai Inc Yantai Shandong Manufacturer 12
Shenzhen Roundwhale Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Easymed Instruments Co., Ltd. Daliang, Shunde, Foshan Guangdong Contract manufacturer 8
Fuji Dynamics Limited Dongguan Guangdong Manufacturer 6
Xemis Medical Technology (Shenzhen) Co., Ltd. Shenzhen Guangdong Manufacturer 6

Record

Regulatory record for Tri-Wave Combination Stimulator
Listed by Elite Medical Supply OF NY
FDA product code LIH
Device type Interferential Current Therapy
Device class Class 2
Regulation 21 CFR 882.5890
Record published 2018-03-16
Record revised 2024-10-24 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number
Packaging Carrying case
Distribution end date 2019-01-01

Catalogue Numbers

Catalogue numbers for Tri-Wave Combination Stimulator
Catalogue number Size Status
EMS100 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
GEM-Stim Gemore Technology Co., Ltd. 14
Well-Life Well-Life Healthcare Limited 14
Winner EVO Combo Drive DeVilbiss Healthcare 4
Winner EVO Stim Drive DeVilbiss Healthcare 3
High Voltage Galvanic Stimulator Kit Control Solutions, Inc. 2
Chattanooga DJO, LLC 2
Dynatron Solaris Plus 709 Dynatronics Corp. 2
BodyMed Boxout, LLC 2
CS6101 Interferential Kit Control Solutions, Inc. 2
Ibramed Ibramed Industria Brasileira de Equipamentos Medicos Eir 2
CS6101-3-K01 Interferential Kit Control Solutions, Inc. 1
Flex-TENS Emsi 1

Showing 12 of 58. All products under Interferential Current Therapy

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer