| Primary Device ID | 00860019001623 |
| NIH Device Record Key | bcdac13c-4a6c-4195-b75e-5d9e95530741 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tri-Wave Combination Stimulator |
| Version Model Number | EMS100 |
| Company DUNS | 608469891 |
| Company Name | ELITE MEDICAL SUPPLY OF NY |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 00860019001623 - Tri-Wave Combination Stimulator | 2019-10-23The 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. |
| 00860019001623 - Tri-Wave Combination Stimulator | 2019-10-23 The Elite Medical Supply of NY EMS100 Tri-Wave Combination Stimulator (the Device) is a battery and 110V wall adapter powered el |
| 00860019001647 - Multi-Mode Stimulator | 2019-10-23 The Elite Medical Supply of NY PMD2000 Multi-Mode Stimulator (MMS) (the Device) is a battery and 110V wall adapter powered elect |
| 00860019001654 - 2x4" Rectangle Fabric Electrode | 2018-11-14 2x4" rectangle white non-woven fabric cutaneous hydrogel electrode, package contains 4 individual electrodes. |
| 00860019001616 - 2" square fabric electrode | 2018-04-19 2" square white non-woven fabric cutaneous hydrogel electrode, package contains 4 individual electrodes. |