FDA device listing
ARTROMOT® ACTIVE-K,ARTROMOT®-E2,ARTROMOT®-E2 Compact,ARTROMOT®-S4,ARTROMOT®-SP3 Comfort,ARTROMOT®-SP3 Comfort…
FDA device listing 1993613208 · DJO, LLC
Key facts
| Proprietary names | ARTROMOT® ACTIVE-K,ARTROMOT®-E2,ARTROMOT®-E2 Compact,ARTROMOT®-S4,ARTROMOT®-SP3 Comfort,ARTROMOT®-SP3 Comfort Chip,ARTROMOT®-SP3 Standard,ARTROMOT®-SP3 Standard Chip,OptiFlex®-K1 Classic,OptiFlex®-K1 Comfort Chip,OptiFlex®-K1 Standard,OptiFlex®-S |
|---|---|
| Owner/operator | DJO, LLC |
| Owner/operator number | 9015378 |
| Product codes | BXB |
| Device names | BXB - Exerciser, Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5380 |
| Review panels | Physical Medicine |
| Registered establishments | DJO Global / Germany, DJO, LLC, MEDIREHA GmbH |
| Establishment registrations | 3003238222, 3007740591, 3017264244 |
| FEI numbers | 3003238222, 3007740591, 3017264244 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Foreign Exporter, Manufacturer, Specification Developer |
| 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