DJO, LLC

Registration Details

Registration Name: DJO, LLC
Registration Number: 3012446970
FEI Number: 2020737
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 3151 Scott St
City: Vista
State: CA
ZIP: 92081
Country: US

Regulatory Submissions

510(k) Number: K091700
PMA Number: P080028

Owner / Operator

Firm Name: DJO, LLC
Operator Number: 9015378
Address: 5919 Sea Otter Place, Suite 200
City: Carlsbad
State: CA
Postal Code: 92010
Country: US
Correspondent: Dave Hunter

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Sleeve, Limb, Compressible	JOW	Class 2	Cardiovascular	No	2010-02-03
Orthosis, Limb Brace	IQI	Class 1	Physical Medicine	No	1998-06-19
Cage, Knee	ITM	Class 1	Physical Medicine	No	1998-06-19
Generator, Shock-Wave, For Pain Relief	NBN	Class 3	Unknown	No	2019-02-26
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	Class 2	Physical Medicine	No	2018-04-06
Pad, Heating, Powered	IRT	Class 2	Physical Medicine	No	2018-04-06
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	Class 2	Neurology	No	2018-04-06
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	Class 2	Neurology	No	2018-04-06
Joint, Knee, External Brace	ITQ	Class 1	Physical Medicine	No	1998-06-19
Lamp, Infrared, Therapeutic Heating	ILY	Class 2	Physical Medicine	No	2009-08-27
Stimulator, Bone Growth, Non-Invasive	LOF	Class 2	Orthopedic	No	2025-07-07

Proprietary Names

VENAFLOW ELITE VenaFlow Elite System & Accessories SPORT WRAP KIT IMAK SMART GLOVE W/THUMB SHOULDER CRADLE LACE-UP WRIST SUPPORT QUICK RELOAD ECONOMY SHOULDER IMMOBILIZER VELOCITY LS PADDED FINGER COT PNEUMATIC ARMBAND VCOMFORT FORM WRIST THUMB A2 WRIST BRACE LERMAN SHOULDER ORTHOSIS ELBOW RANGER PERFORMER ELBOW SUPPORT ABDUCTED THUMB SPICA LITES ELBOW VISCO SCOI SHOULDER BRACE COMFORT FORM WRIST IMAK ELBOW WRAP ELASTIC WRIST BRACE CLINIC TENNIS ELBOW ELASTIC ELBOW SUPPORT DONJOY ELBOW GUARD VDELUXE WRIST FOREARM DONJOY SPORTS THIGH WRAP ARM IMMOBILIZER SLING SAMMONS PRESTON, ARMBAND WRIST-O-PRENE SUPPORT SURROUND FLOAM ELBOW ELASTIC SHOULDER IMMOBILIZER BOOMERANG WRIST SUPPORT ANAFORM WRIST WRAP TENNIS ELBOW BRACE TRIZONE ELBOW BRACE BIONIC ELBOW BRACE TRIZONE CALF SLEEVE ANAFORM ARM SLEEVE ANAFORM CALF SLEEVE ANAFORM SHIN SPLINT SLEEVE MANUFORCE WRIST BRACE EPIFORCE BIONIC REEL-ADJUST WRIST BRACE X-ACT ROM ELBOW BRACE ADVANTAGE STABILIZING ELASTIC WRIST PERFORMANCE WRIST WRAP LONG THUMB SPICA II ARTHRITIS GLOVES ACTYTOE NIGHT SPLINT ACTYTOE LIFT ACTYTOE FOOT BRACE SOFTOES CONDILAX ELBOW SUPPORT ERGOFORM THUMB BRACE CARPAFORM WRIST BRACE RHIZOFORM THUMB BRACE DIGIFORM WRIST-FINGER BRACE DUOFORM WRIST BRACE ADULT DUOFORM WRIST BRACE PEDIATRIC ULTRASLING PRO DIGIFORM FINGER SPLINT ULTRASLING IV ACROMIOCLAVICULAR BRACE-UNIV MAYO CLINIC ELBOW BRACE SHOULDER IMMOBILIZER ENHANCED HYBRID ELS BRACE PLANTAR FASCIITIS STRETCH SAFETY WRIST BRACE WESTERN WRIST SLEEVE ELBOW IMMOBILIZER POSTERIOR ELBOW BRACE POSTURE CLAVICLE SUPPORT SULLY SHOULDER CONTOURED ELASTI-WRAP I-ROM ELBOW CALF SLEEVE UNIVERSAL WRIST SUPPORT BURNHAM THUMB QUICK-FIT WRIST BRACE VQ ABDUCTED THUMB SPICA COLLES SPLINT ELBOW SLEEVE DEFIANCE PINCH GUARD CTS WRIST SUPPORT KODEL CLAVICLE NEO TENNIS ELBOW SPECIALTY SHOULDER IMMOBILIZER DELUXE ROM ELBOW KODEL SHOULDER IMMOB PALM MET ELBOW SPIDER PAD DEFIANCE CUSTOM ADJUSTABLE OA DEFIANCE DEFIANCE III, CCMI FUNCTIONAL KNEE BRACE DEFIANCE III FEMALE FOURCE DEFIANCE III VenaFlow System WEEKENDER PLAYMAKER XPERT SLEEVE Velocity Extension Cuff OA Go CryoKnee Brace ROAM OA KNEE BRACE SUPPORT EVEREST ICE II SLEEVE ManaFuse

Establishment Types

Manufacture Medical Device Repack or Relabel Medical Device