Home › Device types › IQI
Orthosis, Limb Brace
FDA product code IQI · Class 1 · Physical Medicine
3,454
Registered devices
456
Adverse events
17
Recalls
52
510(k) clearances
Devices with this code
DeRoyal — DEROYAL INDUSTRIES, INC.SUPER SLING PLUS LG — Bird & Cronin, LLCWRIST - WESTPORT SM LT — Bird & Cronin, LLCDeRoyal — DEROYAL INDUSTRIES, INC.MEDI — MEDI MANUFACTURING, INC.PROFIT — PANTYMED S.A.MEDI — MEDI MANUFACTURING, INC.DeRoyal — DEROYAL INDUSTRIES, INC.ManaEZ Single Panel Knee Immobilizer 24" — Manamed, Inc.Soft Stride — BROWNMED, INC.MEDI — MEDI MANUFACTURING, INC.DeRoyal — DEROYAL INDUSTRIES, INC.MEDI — MEDI MANUFACTURING, INC.PROFIT — PANTYMED S.A.PROCARE — DJO, LLCSHOULDER IMMOBILIZER UNIV — Bird & Cronin, LLCWRIST - FRAZER 2XL RT — Bird & Cronin, LLCPROFIT — PANTYMED S.A.VELPEAU IMMOBILIZER/SLING XS — Bird & Cronin, LLCMEDI — MEDI MANUFACTURING, INC.Formthotics — FOOT SCIENCE INTERNATIONAL LIMITEDMEDI — MEDI MANUFACTURING, INC.DeRoyal — DEROYAL INDUSTRIES, INC.U2 WRIST UNIV LT — Bird & Cronin, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-23 | Townsend Design | Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. |
| 2023-09-23 | Townsend Design | Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. |
| 2023-09-23 | Townsend Design | Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. |
| 2018-01-31 | 3M Company - Health Care Business | 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The pr |
| 2018-01-31 | 3M Company - Health Care Business | 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The pr |
| 2016-11-07 | DeRoyal Industries Inc | DeRoyal received complaints of mold on Tennis Elbow Straps. |
| 2016-11-07 | DeRoyal Industries Inc | DeRoyal received complaints of mold on Tennis Elbow Straps. |
| 2016-02-24 | Ossur H / F | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound |
| 2016-02-24 | Ossur H / F | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound |
| 2016-02-24 | Ossur H / F | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound |
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