| Primary Device ID | EJKP100004142A0 |
| NIH Device Record Key | 9ff2b2b5-cd88-4e1b-a572-a39ae3cd8fab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ergoline Prestige Fusion Edge |
| Version Model Number | MODEL-NO: JK 205 / 52-4 HLT 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 | EJKP100004142A0 [Primary] |
| LEJ | Booth, Sun Tan |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-13 |
| Device Publish Date | 2026-01-05 |
| EJKP100004142A0 - Ergoline Prestige Fusion Edge | 2026-01-13 |
| EJKP100004142A0 - Ergoline Prestige Fusion Edge | 2026-01-13 |
| EJKP100004143A0 - Ergoline Prestige Synergy EDGE | 2026-01-13 |
| EJKP100004088A0 - Recovery 7200 PF | 2025-12-18 |
| EJKP100003993A0 - Planet Fitness 40/3 HLT Plus | 2025-05-08 |
| EJKP100003996A0 - Ergolline Shine PLT | 2025-05-08 |
| EJKP100003999A0 - Ergoline Pulse PLT | 2025-05-08 |
| EJKP100004000A0 - Ergoline Spirit HLT | 2025-05-08 |
| EJKP100004001A0 - Ergoline Spirit PLT | 2025-05-08 |