FDA device listing
Brace Align ComfortCore TLSO - BKB427,Brace Align Core TLSO LSO Side Stays for Back Braces - ACS435,Brace Align Core…
FDA device listing 1322571560 · Brace Align
Key facts
| Proprietary names | Brace Align ComfortCore TLSO - BKB427,Brace Align Core TLSO LSO Side Stays for Back Braces - ACS435,Brace Align Core VertebrAlign TLSO LSO Side Stays - ACS442,Brace Align FeatherLite Soft TLSO Back Brace - BKB483,Brace Align Postural Correcting TLSO Back Brace - BKB175,Brace Align TLSO Full Back Brace - BKB312,Brace Align TLSO Thoracic Back Support Brace - BKB153,Brace Align TLSO Thoracic Back… |
|---|---|
| Owner/operator | Brace Align |
| Owner/operator number | 10052555 |
| Product codes | IPT |
| Device names | IPT - Orthosis, Thoracic |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3490 |
| 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