| Primary Device ID | EJKP100003173A0 |
| NIH Device Record Key | ebd12afa-ef57-47eb-b9da-99d5ba2b5401 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ergoline/Inspiration 500 Smart Performance, Soltron M-55 RACER |
| Version Model Number | JK 126 / 38-3 AC |
| Company DUNS | 316232073 |
| Company Name | JK-Products GmbH |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EJKP100003173A0 [Primary] |
| LEJ | Booth, Sun Tan |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| EJKP100004042A0 - Ergoline Vitality Pure Light 3 (10 min) | 2024-03-07 |
| EJKP100003952B0 - Revive | 2023-12-11 |
| EJKP100003960B0 - Revive RVT30 | 2023-12-11 |
| EJKP100003973A0 - Revive PRO IR | 2023-11-23 |
| EJKP100003892A0 - VITALITY 46/3 PLT AC USA | 2023-06-08 |
| EJKP100003946A0 - Ergoline/PASSION PLUS 40/3 Smart Performance | 2023-06-08 |
| EJKP100003952A0 - Revive 7200 | 2023-06-08 |
| EJKP100003960A0 - Revive RVT30 | 2023-05-08 |