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…
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.
Who Else Makes It
Concentrated in Guangdong (6), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| 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
| 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
| 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 number | Size | Status |
|---|---|---|
| EMS100 | Withdrawn |
Same 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.