FDA device listing
Back Bandit Excel,Back Bandit Pro Plus,Back Bandit Pro (TLSO),Back Bandit Ultima,Miracle Back,Miracle Back…
FDA device listing 1050181485 · Doctor In The House
Key facts
| Proprietary names | Back Bandit Excel,Back Bandit Pro Plus,Back Bandit Pro (TLSO),Back Bandit Ultima,Miracle Back,Miracle Back Optima,Miracle Back Premier,Miracle Back Pro,Miracle Back Pro ll,Miracle Back (TLSO) from Doctor in the House,Miracle Back Ultra,The Back Bandit (TLSO) from Doctor in the House |
|---|---|
| Owner/operator | Doctor In The House |
| Owner/operator number | 10039759 |
| Product codes | MRI |
| Device names | MRI - Orthosis, Truncal/Orthosis, Limb |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3490 |
| Review panels | Physical Medicine |
| Registered establishments | DOCTOR IN THE HOUSE |
| Establishment registrations | 3009491775 |
| FEI numbers | 3009491775 |
| 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