FDA device listing
Postpartum Belly Band, Abdominal Support, Wrist Support; Pelvic Support Belt,Wrist Brace, Wrist Support, Wrist Warp…
FDA device listing 1084167496 · Hengshui Runde Medical Instruments Co.,Ltd
Key facts
| Proprietary names | Postpartum Belly Band, Abdominal Support, Wrist Support; Pelvic Support Belt,Wrist Brace, Wrist Support, Wrist Warp, Wrist Band; Maternity Belt, Maternity Support Belt |
|---|---|
| Owner/operator | Hengshui Runde Medical Instruments Co.,Ltd |
| Owner/operator number | 10053121 |
| Product codes | ISR |
| Device names | ISR - Band Or Belt, Pelvic Support |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3025 |
| Review panels | Physical Medicine |
| Registered establishments | HENGSHUI RUNDE MEDICAL INSTRUMENTS CO.,LTD |
| Establishment registrations | 3010785927 |
| FEI numbers | 3010785927 |
| 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