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Orthosis, Limb Brace
FDA product code IQI · Class 1 · Physical Medicine
3,557
Registered devices
458
Adverse events
17
Recalls
52
510(k) clearances
Devices with this code
Soft Stride — BROWNMED, INC.INDEPENDENCE WRIST 9" XS LT — Bird & Cronin, LLCMEDI — MEDI MANUFACTURING, INC.MEDI — MEDI MANUFACTURING, INC.Panacea — Blake Manufacturing, Inc.MEDI — MEDI MANUFACTURING, INC.VQ ORTHOCARE — Vision Quest Industries IncorporatedPediHip — ORTHOPEDIATRICS CORP.MyoPro 2x Assembly Kit — Myomo, Inc.MEDI — MEDI MANUFACTURING, INC.ComfyHealth — Comfy Health Group Co., Ltd.DeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.PROFIT — PANTYMED S.A.DeRoyal — DEROYAL INDUSTRIES, INC.VQ ORTHOCARE — Vision Quest Industries IncorporatedWALGREEN — WALGREEN CO.MEDI — MEDI MANUFACTURING, INC.DeRoyal — DEROYAL INDUSTRIES, INC.PediHip — ORTHOPEDIATRICS CORP.Formthotics — FOOT SCIENCE INTERNATIONAL LIMITEDPush braces — Nea International B.V.Stat-A-Dyne Ankle — LANTZ MEDICAL, INC.Plantar Fasciitis Stretch Splint — 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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