FDA device listing
Lenyo Child,Lenyo Fitness,Lenyo Fitness Mobile,Lenyo Fractal,Lenyo Fractal Meridian,Lenyo Harmony,Lenyo Horse,Lenyo…
FDA device listing 1009229139 · LENYO WORLD LTD
Key facts
| Proprietary names | Lenyo Child,Lenyo Fitness,Lenyo Fitness Mobile,Lenyo Fractal,Lenyo Fractal Meridian,Lenyo Harmony,Lenyo Horse,Lenyo Horse Mobile,Lenyo Lux Plus,Lenyo Lux Pro,Lenyo Meridian,Lenyo Mobile,Lenyo Mobile Lady,Lenyo Mobile Pet,Lenyo Mobile Port,Lenyo Newborn,Lenyo Office,Lenyo One Pulse Mobile,Lenyo SanoCenter,Lenyo Sleep,Lenyo Space Harmoniser,Lenyo Sport,Lenyo Ultra Wellness Mobile,Lenyo Woman,Lenyo… |
|---|---|
| Owner/operator | LENYO WORLD LTD |
| Owner/operator number | 10086719 |
| Product codes | ISA |
| Device names | ISA - Massager, Therapeutic, Electric |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5660 |
| Review panels | Physical Medicine |
| Registered establishments | LENYO WORLD LTD |
| Establishment registrations | 3025350087 |
| FEI numbers | 3025350087 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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