FDA device listing
A60 ANKLE BRACE,ACTIVE ANKLE T1 ORTHOSIS,Advanced Dynamic ROM Orthosis,AIRGO,AIRHEEL,AIRLIFT PTTD ANKLE…
FDA device listing 1611320204 · DJO, LLC
Key facts
| Proprietary names | A60 ANKLE BRACE,ACTIVE ANKLE T1 ORTHOSIS,Advanced Dynamic ROM Orthosis,AIRGO,AIRHEEL,AIRLIFT PTTD ANKLE BRACE,AirSport+,AIRSPORT BRACE,AIR-STIRRUP,AIR-STIRRUP™ ANKLE BRACE,AIR STIRRUP II ANKLE BRACE,ALP II,ANKLE BRACES,ANKLET,Bionic Ankle Brace,DELUX ANKLE,Donjoy ACHILLOFORCE AIR,DONJOY SPORTS ANKLE,DOUBLE STRAP ANKLE WRAP,DRYTEX,ROCKETSOC,ECONOSOC,EXCELERATOR ANKLE STIRRUP,Exos FreeMotion… |
|---|---|
| Owner/operator | DJO, LLC |
| Owner/operator number | 9015378 |
| Product codes | ITW |
| Device names | ITW - Joint, Ankle, External Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | DJO FRANCE SAS, DJO, LLC, DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V., DJO Tunisia, DJO Tunisie |
| Establishment registrations | 9616086, 3007502541, 3007615436, 3011120089, 3017264244 |
| FEI numbers | 3006076154, 3007502541, 3007615436, 3011120089, 3017264244 |
| Establishment operations | Foreign Exporter, Specification Developer, 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