FDA device listing
Calf care device,Knee massager,Leg massager,lower back stretching massager,Lumbar massage belt,Lumbar massager,Lumbar…
FDA device listing 1366387562 · JIANGSU ALPHAY INTERNATIONAL TRADE CO., LTD.
Key facts
| Proprietary names | Calf care device,Knee massager,Leg massager,lower back stretching massager,Lumbar massage belt,Lumbar massager,Lumbar Traction Device; CERVICAL CARE DEVICE,Neck massager |
|---|---|
| Owner/operator | JIANGSU ALPHAY INTERNATIONAL TRADE CO., LTD. |
| Owner/operator number | 10023966 |
| 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 | JIANGSU ALPHAY MEDICAL DEVICE CO., LTD. |
| Establishment registrations | 3006891384 |
| FEI numbers | 3006891384 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, 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