FDA device listing
Maptag Male Sexual Function Rehabilitation Therapy Apparatus, Include 3 Models,,Maptag MP-3521 Household Male Sexual…
FDA device listing 1130394996 · Dolanvy (Suzhou) Medical Technology Co., Ltd
Key facts
| Proprietary names | Maptag Male Sexual Function Rehabilitation Therapy Apparatus, Include 3 Models,,Maptag MP-3521 Household Male Sexual Function Rehabilitation Therapy Apparatus,,Maptag MP-3522 Household Male Sexual Function Rehabilitation Therapy Apparatus,,Maptag SW-3503 Male Sexual Function Rehabilitation Therapy Apparatus,Nocturnal Penile Tumescence Apparatus: SW-3620 |
|---|---|
| Owner/operator | Dolanvy (Suzhou) Medical Technology Co., Ltd |
| Owner/operator number | 10086351 |
| Product codes | LKY |
| Device names | LKY - Device, External Penile Rigidity |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5020 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Dolanvy (Suzhou) Medical Technology Co., Ltd |
| Establishment registrations | 3025376109 |
| FEI numbers | 3025376109 |
| 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