Thuasne, LLC
Hamlet, NC, US
Thuasne, LLC appears in FDA device records in Hamlet, NC. FDA records list no 510(k) clearances, no PMA records and 6 registered establishments. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Thuasne, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Corflexenforcement report, recall
- Townsend Designenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1064876 | 3003185541 | Thuasne, LLC | 167 Marks Creek Ln, Hamlet, NC 28345 US | 2026 | |
| 1218997 | 1218997 | Thuasne, LLC | 669 EAST INDUSTRIAL PARK, MANCHESTER, NH 03109 US | 2026 | |
| 1922710 | 1922710 | Thuasne, LLC | 120 OSAGE AVE, KANSAS CITY, KS 66105 US | 2026 | |
| 2951574 | 1000523125 | Thuasne, LLC | 4615 SHEPARD ST., BAKERSFIELD, CA 93313 US | 2026 | and 5 more, listed in full below |
| 3015258656 | 3015258656 | Thuasne, LLC | 123 Osage Ave., Kansas City, KS 66105 US | 2026 | No device listings on this registration |
| 3025770454 | 3025770454 | Thuasne, LLC | J. Ruiz de Alarcon 317, Chihuahua 31136 MX | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FSDBinder, Abdominal
- MDRBinder, Medical, Therapeutic
- IPMCover, Limb
- MHWDressing, Compression
- JFAExerciser, Finger, Powered
- ITWJoint, Ankle, External Brace
- ITQJoint, Knee, External Brace
- IQKOrthosis, Cervical
- IQIOrthosis, Limb Brace
- IQEOrthosis, Lumbar
- IPYOrthosis, Lumbo-Sacral
- IPTOrthosis, Thoracic
- IMEPack, Hot Or Cold, Reusable
- ISSProsthesis, Thigh Socket, External Component
- ILISling, Arm
- IQJSplint, Clavicle
- ILHSplint, Hand, And Components
- IQMSplint, Temporary Training
- ILGStocking, Elastic
- FQLStocking, Medical Support (For General Medical Purposes)
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- IOYSupport, Arm
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0672-2024 | SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX | Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. | Class II | Completed | |
| Z-0671-2024 | SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037 | Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. | Class II | Completed | |
| Z-0670-2024 | CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040 | Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. | Class II | Completed | |
| Z-0580-2016 | CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. | Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, | Class II | Terminated | |
| Z-0579-2016 | ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. | Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, | Class II | Terminated | |
| Z-0578-2016 | BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. | Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, | Class II | Terminated | |
| Z-0577-2016 | ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. | Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, | Class II | Terminated | |
| Z-0576-2016 | HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. | Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, | Class II | Terminated | |
| Z-0575-2016 | CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. | Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, | Class II | Terminated | |
| Z-0574-2016 | Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. | Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain