FDA device listing
3D Design Only, A1 - Pro Sport,A10 - Easy Flex, A100 - Solid Ankle,A11 - Cushion Plus,A12 - Unit A2 - Carbon Sport, A3…
FDA device listing 1007490902 · KevinRoot Medical
Key facts
| Proprietary names | 3D Design Only, A1 - Pro Sport ,A10 - Easy Flex, A100 - Solid Ankle ,A11 - Cushion Plus,A12 - Unit A2 - Carbon Sport, A3 - Classic Sport ,A4 - Subo-Flex, A5 - Supporter ,A6 - Cork & Leather, A7 - Pro EVA A8,A9 - Coleman, Carbon Footplate Rigid, Carbon Footplate Semi-Rigid, CE - Control EVA, CP - Control Polypro,CT - Control TL Carbon, CX - Control ,XT Carbon, DP - Dress Polypro, DT - Dress TL… |
|---|---|
| Owner/operator | KevinRoot Medical |
| Owner/operator number | 10091892 |
| Product codes | KNP |
| Device names | KNP - Orthosis, Corrective Shoe |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | KEVINROOT MEDICAL |
| Establishment registrations | 3021443431 |
| FEI numbers | 3021443431 |
| 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