FDA device listing
Brace Direct Ankle & Foot Gel Ice Pack - ACS272,Brace Direct Back Brace Hot or Cold Therapy Pack - ACS447,Brace Direct…
FDA device listing 1623157831 · Brace Align
Key facts
| Proprietary names | Brace Direct Ankle & Foot Gel Ice Pack - ACS272,Brace Direct Back Brace Hot or Cold Therapy Pack - ACS447,Brace Direct Back Ice Pack Insert for Back Braces - ACS236,Brace Direct Calf Ice Pack Wrap with Compression - CTY195,Brace Direct Cold Compression Knee Wrap - CTY178-2,Brace Direct CoolForce Shoulder Cold Compression System - CTY637-5510,Brace Direct Cryotherapy Air Pump Ankle Foot Wrap… |
|---|---|
| Owner/operator | Brace Align |
| Owner/operator number | 10052555 |
| Product codes | IME |
| Device names | IME - Pack, Hot Or Cold, Reusable |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5700 |
| Review panels | Physical Medicine |
| Registered establishments | BRACE ALIGN |
| Establishment registrations | 3013002868 |
| FEI numbers | 3013002868 |
| Establishment operations | Repackager/Relabeler, 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