FDA device listing
BM-F0112A BM-F0113A BM-F0113B BM-F0113C BM-ZF0111A BM-ZF0112A BM-ZF0114A BM-ZF0115A BM-F0120A BM-F0121A…
FDA device listing 1390740630 · Dongguan Sainvie Health Technology Co.,Ltd.
Key facts
| Proprietary names | BM-F0112A BM-F0113A BM-F0113B BM-F0113C BM-ZF0111A BM-ZF0112A BM-ZF0114A BM-ZF0115A BM-F0120A BM-F0121A BM-F0122A,BM-F0123A BM-F0210A BM-F0211A BM-F0212A BM-F0213A BM-F0213B BM-F0213C BM-ZF0211A BM-ZF0212A BM-ZF0214A BM-ZF0215A,BM-F0220A BM-F0221A BM-F0222A BM-F0223A BM-F0310A BM-F0311A BM-F0312A BM-F0313A BM-F0313B BM-F0313C BM-ZF0311A,BM-ZF0312A BM-ZF0314A BM-ZF0315A BM-F0320A BM-F0321A… |
|---|---|
| Owner/operator | Dongguan Sainvie Health Technology Co.,Ltd. |
| Owner/operator number | 10089499 |
| Product codes | IRT |
| Device names | IRT - Pad, Heating, Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.5740 |
| Review panels | Physical Medicine |
| Registered establishments | DONGGUAN SAINVIE HEALTH TECHNOLOGY CO.,LTD. |
| Establishment registrations | 3030507593 |
| FEI numbers | 3030507593 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| 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