FDA device listing
Comfort Belt,Hot Cold Comfort Belt (with the pack),Hot Cold Pack
FDA device listing 1717131420 · Health Plus (Shanghai) International Co., LTD
Key facts
| Proprietary names | Comfort Belt,Hot Cold Comfort Belt (with the pack),Hot Cold Pack |
|---|---|
| Owner/operator | Health Plus (Shanghai) International Co., LTD |
| Owner/operator number | 10059733 |
| Product codes | IME |
| Device names | IME - Pack, Hot Or Cold, Reusable |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5700 |
| Review panels | Physical Medicine |
| Registered establishments | HEALTH PLUS (SHANGHAI) INTERNATIONAL CO., LTD |
| Establishment registrations | 3015339737 |
| FEI numbers | 3015339737 |
| 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