FDA device listing
Neoprene AK Susp Belt, Xlg,Neoprene A.K. Suspension Belt, Large,Neoprene A.K. Suspension Belt, Medium,Neoprene A.K…
FDA device listing 1712391443 · TIBURON MEDICAL ENTERPRISES
Key facts
| Proprietary names | Neoprene AK Susp Belt, Xlg,Neoprene A.K. Suspension Belt, Large,Neoprene A.K. Suspension Belt, Medium,Neoprene A.K. Suspension Belt, Small |
|---|---|
| Owner/operator | TIBURON MEDICAL ENTERPRISES |
| Owner/operator number | 9040187 |
| 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 | TIBURON MEDICAL ENTERPRISES, Zeffer Research & Assoc. S. A. de C. V. |
| Establishment registrations | 2031918, 3007392395 |
| FEI numbers | 3002935344, 3007392395 |
| Establishment operations | Contract Manufacturer, 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