| Primary Device ID | 00815290016576 |
| NIH Device Record Key | 8e4419ce-ca1c-4946-9122-256cfa9b96a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Therapist’s Choice® EMS 250 |
| Version Model Number | EMS 250 |
| Catalog Number | EMS 250 |
| Company DUNS | 004416769 |
| Company Name | CLINICAL HEALTH SERVICES, INC. |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815290016552 [Primary] |
| GS1 | 00815290016569 [Package] Contains: 00815290016552 Package: Inner Box [5 Units] In Commercial Distribution |
| GS1 | 00815290016576 [Package] Contains: 00815290016569 Package: Master Case [8 Units] In Commercial Distribution |
| IPF | Stimulator, Muscle, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2019-08-02 |
| 10815290019406 - ePower® T1 TENS UNIT | 2023-09-25 ePower® T1 TENS UNIT |
| 10815290019413 - ePower® T2 DIGITAL TENS | 2023-09-25 ePower® T2 DIGITAL TENS |
| 10815290019420 - ePower® TE2 COMBO TENS & EMS | 2023-09-25 ePower® TE2 COMBO TENS & EMS |
| 10815290019239 - ePower® | 2023-07-24 ePower® E1 EMS UNIT: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder, low back |
| 10815290019246 - ePower® | 2023-07-24 ePower® E2 DIGITAL EMS: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder, low b |
| 10815290019161 - Clinical Health Services, Inc. | 2023-06-01 R95D 3.75" Round, 3.75 Round Electrode, Standard Pin |
| 10815290018881 - Clinical Health Services, Inc. | 2022-11-01 TC120R-WC, 2" Round electrodes, white cloth, carbon, plastic zip lock |
| 10815290018720 - Therapist’s Choice® TENS 3MT | 2022-06-10 Therapist’s Choice® TENS 3MT: It is used for temporary relief of pain associated with sore and aching muscles in the shoulde |