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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: A2 WRIST BRACE; ABDUCTED THUMB SPICA; ACROMIOCLAVICULAR BRACE-UNIV; ACTYTOE FOOT BRACE; ACTYTOE LIFT; ACTYTOE NIGHT SPLINT; ADVANTAGE STABILIZING ELASTIC WRIST; ANAFORM ARM SLEEVE; ANAFORM CALF SLEEVE; ANAFORM SHIN SPLINT SLEEVE; ANAFORM WRIST WRAP; ARM IMMOBILIZER SLING; ARTHRITIS GLOVES; BIONIC ELBOW BRACE; BIONIC REEL-ADJUST WRIST BRACE; BOOMERANG WRIST SUPPORT; BURNHAM THUMB; CALF SLEEVE; CARPAFORM WRIST BRACE; CLINIC TENNIS ELBOW; COLLES SPLINT; COMFORT FORM WRIST; CONDILAX ELBOW SUPPORT; CONTOURED ELASTI-WRAP; CTS WRIST SUPPORT; DEFIANCE PINCH GUARD; DELUXE ROM ELBOW; DIGIFORM FINGER SPLINT; DIGIFORM WRIST-FINGER BRACE; DONJOY ELBOW GUARD; DONJOY SPORTS THIGH WRAP; DUOFORM WRIST BRACE ADULT; DUOFORM WRIST BRACE PEDIATRIC; ELASTIC ELBOW SUPPORT; ELASTIC SHOULDER IMMOBILIZER; ELASTIC WRIST BRACE; ELBOW IMMOBILIZER; ELBOW RANGER; ELBOW SLEEVE; ELBOW SPIDER PAD; ENHANCED HYBRID ELS BRACE; EPIFORCE; ERGOFORM THUMB BRACE; I-ROM ELBOW; IMAK ELBOW WRAP; IMAK SMART GLOVE W/THUMB; KODEL CLAVICLE; KODEL SHOULDER IMMOB; LACE-UP WRIST SUPPORT; LERMAN SHOULDER ORTHOSIS; LITES ELBOW VISCO; LONG THUMB SPICA II; MANUFORCE WRIST BRACE; MAYO CLINIC ELBOW BRACE; NEO TENNIS ELBOW; PADDED FINGER COT; PALM MET; PERFORMANCE WRIST WRAP; PERFORMER ELBOW SUPPORT; PLANTAR FASCIITIS STRETCH; PNEUMATIC ARMBAND; POSTERIOR ELBOW BRACE; POSTURE CLAVICLE SUPPORT; QUICK RELOAD ECONOMY SHOULDER IMMOBILIZER; QUICK-FIT WRIST BRACE; RHIZOFORM THUMB BRACE; SAFETY WRIST BRACE; SAMMONS PRESTON, ARMBAND; SCOI SHOULDER BRACE; SHOULDER CRADLE; SHOULDER IMMOBILIZER; SOFTOES; SPECIALTY SHOULDER IMMOBILIZER; SPORT WRAP KIT; SULLY SHOULDER; SURROUND FLOAM ELBOW; TENNIS ELBOW BRACE; TRIZONE CALF SLEEVE; TRIZONE ELBOW BRACE; ULTRASLING IV; ULTRASLING PRO; UNIVERSAL WRIST SUPPORT; VCOMFORT FORM WRIST THUMB; VDELUXE WRIST FOREARM; VELOCITY LS; VQ ABDUCTED THUMB SPICA; WESTERN WRIST SLEEVE; WRIST-O-PRENE SUPPORT; X-ACT ROM ELBOW BRACE
Classification Name: ORTHOSIS, LIMB BRACE
Product Code: IQI
Device Class: 1
Regulation Number: 890.3475
Medical Specialty: Physical Medicine
Registered Establishment Name: DJO FRANCE SAS
Registered Establishment Number: 3007502541
Owner/Operator: DJO, LLC
Owner/Operator Number: 9015378
Establishment Operations: Foreign Exporter; Specification Developer
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