FDA device listing
Ergoline Sunrise 6200 Basic Design,Ergoline Sunrise 6200 Basic Design / Sound / Bluetooth / Vibra Shape,Ergoline Sunrise…
FDA device listing 1810482480 · JK Products & Services
Key facts
| Proprietary names | Ergoline Sunrise 6200 Basic Design,Ergoline Sunrise 6200 Basic Design / Sound / Bluetooth / Vibra Shape,Ergoline Sunrise 6200 Planet Fitness,Ergoline Sunrise 6200 Planet Fitness / Sound / Bluetooth / Vibra Shape,Ergoline Sunrise 7200 Advanced Design,Ergoline Sunrise 7200 Advanced Design / Sound / Bluetooth / Vibra Shape |
|---|---|
| Owner/operator | JK Products & Services |
| Owner/operator number | 2311923 |
| Premarket submissions | K173565 |
| 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
- None 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