FDA device listing
Ergoline/AFFINITY 500 Turbo Power,Ergoline/AFFINITY 600 Turbo Power Air Condition,Ergoline/AFFINITY 700 Advanced…
FDA device listing 1745758677 · JK Products & Services
Key facts
| Proprietary names | Ergoline/AFFINITY 500 Turbo Power,Ergoline/AFFINITY 600 Turbo Power Air Condition,Ergoline/AFFINITY 700 Advanced Performance AC / Soltron L-70 BUTTERFLY,Ergoline/AFFINITY 700 Advanced Performance / Soltron L-70 BUTTERFLY,Ergoline/AFFINITY 800 Turbo Power Temptronic,Ergoline/AFFINITY 900 Advanced Performance / Soltron XL-85 WILDCAT,Ergoline/ ESSENCE 48 SMART POWER (Grey) / Soltron V-50 SPACE… |
|---|---|
| Owner/operator | JK Products & Services |
| Owner/operator number | 2311923 |
| Premarket submissions | K151400 |
| Product codes | LEJ |
| Device names | LEJ - Booth, Sun Tan |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4635 |
| Review panels | General & Plastic Surgery |
| Registered establishments | JK PRODUCTS & SERVICES, INC. |
| Establishment registrations | 2311923 |
| FEI numbers | 2311923 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database