Panels › Physical Medicine › Product code IQI · Class 1
Orthosis, Limb Brace
Regulation 890.3475
0510(k)s in 12 months (52 all time)
0recalls in 12 months (17 all time)
0recalls that name a 510(k)
Top companies in IQI
| Company | 510(k)s | Recalls |
|---|---|---|
| Fred Sammons, Inc. | 7 | 0 |
| Ossur H / F | 0 | 7 |
| Orthomedics | 5 | 0 |
| Conphar, Inc. | 4 | 0 |
| Hosmer Dorrance Corp. | 3 | 0 |
| Townsend Design | 0 | 3 |
| 3M Company - Health Care Business | 0 | 2 |
| Aircast, Inc. | 2 | 0 |
| Arco Matic, Inc. | 2 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2024 | Townsend Design SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX Completed |
IQI | None listed |
| Jan 5, 2024 | Townsend Design SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis
(AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 1 Completed |
IQI | None listed |
| Jan 5, 2024 | Townsend Design CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis
(AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040 Completed |
IQI | None listed |
| Jan 31, 2018 | 3M Company - Health Care Business ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7 Terminated |
IQI | None listed |
| Jan 31, 2018 | 3M Company - Health Care Business FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6 Terminated |
IQI | None listed |
| Nov 7, 2016 | DeRoyal Industries Inc PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only,
Product Usage:
Lateral and medial epicondylitis Terminated |
IQI | None listed |
| Nov 7, 2016 | DeRoyal Industries Inc TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only,
Product Usage:
Lateral and medial epicondylitis Terminated |
IQI | None listed |
| Feb 24, 2016 | Ossur H / F Extreme Custom
Product Usage:
Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. Terminated |
IQI | None listed |
| Feb 24, 2016 | Ossur H / F Unloader Custom
Product Usage:
Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. Terminated |
IQI | None listed |
| Feb 24, 2016 | Ossur H / F Unloader Custom Lite
Product Usage:
Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. Terminated |
IQI | None listed |
| Feb 24, 2016 | Ossur H / F Unloader XT
Product Usage:
Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. Terminated |
IQI | None listed |
| Feb 24, 2016 | Ossur H / F Rebound Cartilage Custom
Product Usage:
Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis. Terminated |
IQI | None listed |
| Feb 24, 2016 | Ossur H / F Rebound Cartilage
Product Usage:
Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis. Terminated |
IQI | None listed |
| Feb 24, 2016 | Ossur H / F Knee Shield (Patella Cup)
Product Usage:
Knee Shield patella cup is an accessory used with the knee braces to provide protection from debris or impact to the patella while a patient participates in m Terminated |
IQI | None listed |
| May 23, 2015 | United Surgical Associates Keo Brace, elastic wrist brace for carpal tunnel.
A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to preven Terminated |
IQI | None listed |
| Apr 10, 2014 | Breg Inc K-Lite Knee 2 Stays with Visco, Model No. 122015.
Product Usage:
The product is intended to provide flexible knee support. Terminated |
IQI | None listed |
| Apr 10, 2014 | Breg Inc Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415.
Product Usage: The product is intended to provide flexible knee support. Terminated |
IQI | None listed |
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