Profile: DJO Incorporated is a provider of orthopedic devices. We offer a wide range of products used for rehabilitation, pain management and physical therapy. We also develop, manufacture and distribute a broad range of surgical reconstructive implant products. Our service marks and brand names include Encore, Cefar®, Empi®, Ormed®, Chattanooga, Compex®, EmpiCare®, Aircast®, DonJoy®, OfficeCare®, and ProCare®. We specialize in non-surgical orthopedic rehabilitation devices. Our products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other health care professionals.

The company was founded in 1978, has ~4000 employees.

FDA Registration Number: 2020737

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• Abdominal Binders (FDA Code: FSD / 880.5160)

• Abdominal Orthosis (FDA Code: KTD / 890.3490) A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

• Ac-Powered Patient Lifts (FDA Code: FNG / 880.5500) An AC-powered lift is an electrically powered device either fixed or mobile, used to lift and transport patients in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and slings to support the patient.

• Adhesive Bandages (FDA Code: KGX / 880.5240) A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.

• Ankle Braces

• Ankle Braces & Supports

• Arm Slings (FDA Code: ILI / 890.3640) An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

• Arm Supports (FDA Code: IOY / 890.3475) A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

• Biofeedback Device (FDA Code: HCC / 882.5050) A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.

• Bone Growth Stimulators

• Breast Binder (FDA Code: HEF / 880.5160)

• Calipers (FDA Code: KTZ / 888.4150) A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.

• Cast Component (FDA Code: LGF / 888.5940) A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.

• Cast Shoe (FDA Code: IPG / 890.3025) A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.

• Catheter Accessories (FDA Code: KGZ / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Cervical Orthosis (FDA Code: IQK / 890.3490)

• Chilling Unit (FDA Code: IMF / 890.5940) A chilling unit is a refrigerative device intended for medical purposes to chill and maintain cold packs at a reduced temperature.

• Clavicle Splint (FDA Code: IQJ / 890.3490)

• Compressible Limb Sleeve (FDA Code: JOW / 870.5800) A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

• Compression Dressing (FDA Code: MHW / 880.5075) An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.

• Congenital Hip Dislocation Abduction Splint (FDA Code: IOZ / 890.3665) A congenital hip dislocation abduction splint is a device intended for medical purposes to stabilize the hips of a young child with dislocated hips in an abducted position (away from the midline).

• Corrective Shoe Orthosis (FDA Code: KNP / 890.3475)

• Cranial Helmet For Protective Use (FDA Code: NDA / 890.3025)

• Crutch (FDA Code: IPR / 890.3150) A crutch is a device intended for medical purposes for use by disabled persons to provide minimal to moderate weight support while walking.

• Crutch and Walker Cane Tips (FDA Code: INP / 890.3790) Cane, crutch, and walker tips and pads are rubber (or rubber substitute) device accessories intended for medical purposes that are applied to the ground end of mobility aids to prevent skidding or that are applied to the body contact area of the device for comfort or as an aid in using an ambulatory assist device.

• Cuffing System

• Diagnostic Ultrasonic Transducer (FDA Code: ITX / 892.1570) A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

• Disposable Hot/Cold Pack (FDA Code: IMD / 890.5710) A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

• Elastic Bandages (FDA Code: FQM / 880.5075)

• Electrical-Powered Muscle Stimulator (FDA Code: IPF / 890.5850) A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

• Electrode Cables (FDA Code: IKD / 890.1175) An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.

• Electrotherapy Equipment

• Emesis Basin (FDA Code: FNY / 880.6730) A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.

• Exercise Component (FDA Code: IOD / 890.5350) An exercise component is a device that is used in conjunction with other forms of exercise and that is intended for medical purposes, such as to redevelope muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include weights, dumbbells, straps, and adaptive hand mitts.

• Exercise Parallel Bars (FDA Code: IOE / 890.5370) Nonmeasuring exercise equipment consist of devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a prone scooter board, parallel bars, a mechanical treadmill, an exercise table, and a manually propelled exercise bicycle.

• External Ankle Brace (FDA Code: ITW / 890.3475)

• External Brace Component Stirrup (FDA Code: ITC / 890.3410) An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.

• External Brace Hip Joint (FDA Code: ITS / 890.3475)

• External Brace Knee Joint (FDA Code: ITQ / 890.3475)

• External Component Thigh Socket Prosthesis (FDA Code: ISS / 890.3420) An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

• External Functional Neuromuscular Stimulator (FDA Code: GZI / 882.5810) An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

• External Limb Component Knee Joint (FDA Code: ISY / 890.3420)

• Fluidotherapy Units (FDA Code: LSB / 890.5100)

• Hand Splint and Component (FDA Code: ILH / 890.3475)

• Hernia Support (FDA Code: EXN / 876.5970) A hernia support is a device, usually made of elastic, canvas, leather, or metal, that is intended to be placed over a hernial opening (a weakness in the abdominal wall) to prevent protrusion of the abdominal contents. This generic type of device includes the umbilical truss.

• Hot & Cold Therapy Products, Moist Heat Pack

• Ice Bags (FDA Code: KYR / 880.6050) An ice bag is a device intended for medical purposes that is in the form of a container intended to be filled with ice that is used to apply dry cold therapy to an area of the body. The device may include a holder that keeps the bag in place against an external area of the patient.

• Impactor (FDA Code: HWA / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Interferential Current Therapy Unit (FDA Code: LIH / 882.5890)

• Intermittent Pressure Measurement System (FDA Code: JFC / 890.1600) An intermittent pressure measurement system is an evaluative device intended for medical purposes, such as to measure the actual pressure between the body surface and the supporting media.