Profile: CFI Medical Solutions is a manufacturing powerhouse and a cutting-edge engineering resource for original equipment manufacturers (OEMs). Our product categories are medical imaging, operating accessories and rehabilitation. Our product list comprises of ear laminograph block, replacement straps for the shield, table pad, patient transfer boards, surgical table pads and knee spreader. The knee spreader is used to keep the legs separated when sitting in a wheelchair or bed. It is equipped with Velcro® fasteners. The knee spreader is designed to separate the patient's legs while they are lying on their side.

The company was founded in 1970, has revenues of USD 10-25 Million, has ~300 employees and is ISO 13485:2003, CE certified.

FDA Registration Number: 1825560

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• AC-Powered Operating Room Table (FDA Code: FQO / 878.4960) Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

• AC-Powered Surgical Chair (FDA Code: GBB / 878.4960)

• AutoTraction Straps

• Backrest Adjustable Pad

• Body Security Strap Sets

• C-Arm Imaging Drapes

• Camera Cover

• Cervical Headrests

• Chin Strap

• Corrective Shoe Orthosis (FDA Code: KNP / 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.

• Cuffing System

• Disposable Surgical Drape (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• Disposable Surgical Instrument (FDA Code: KDC / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Ear Laminograph Blocks

• Elastic Bandages (FDA Code: FQM / 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.

• Electric Cystometric Table (FDA Code: MMZ / 876.4890) A urological table and accessories is a device that consists of a table, stirrups, and belts used to support a patient in a suitable position for endoscopic procedures of the lower urinary tract. The table can be adjusted into position manually or electrically.

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Examination and Treatment Chair (FDA Code: FRK / 880.6140) A medical chair or table is a device intended for medical purposes that consists of a chair or table without wheels and not electrically powered which, by reason of special shape or attachments, such as food trays or headrests, or special features such as a built-in raising and lowering mechanism or removable arms, is intended for use of blood donors, geriatric patients, or patients undergoing treatment or examination.

• External Inflatable Extremity Splint (FDA Code: FZF / 878.3900) An inflatable extremity splint is a device intended to be inflated to immobilize a limb or an extremity.

• Forehead Straps

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• General & Plastic Surgery Surgical Microscope (FDA Code: FSO / 878.4700) A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

• Knee Separators

• Knee Spreaders

• Laboratory Freezers (FDA Code: JRM / 862.2050) General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

• Limb Brace Orthosis (FDA Code: IQI / 890.3475)

• Lumbar Roll

• Microsurgical Still Camera (FDA Code: FTH / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures.

• Microsurgical Television Camera without Audio (FDA Code: FWD / 878.4160)

• Mobile Fluoroscopic X-Ray System (FDA Code: IZL / 892.1720) A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Mobile X-Ray System (FDA Code: IZL / 892.1720)

• Non-Electrical Urological Table (FDA Code: EYH / 876.4890)

• Non-Protective Wheelchair Restraint (FDA Code: KID / 890.3910) A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.

• Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF / 880.6025) An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

• Nonresorbable Gauze/sponge for External Use (FDA Code: NAB / 878.4014) A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

• Operating Room Scrub Brush (FDA Code: GEC / 878.4800)

• Operating-Room Table and Attachments (FDA Code: BWN / 878.4950) A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

• Ophthalmic AC-Powered Operating Microscope and Accessories (FDA Code: HRM / 878.4700)

• Personnel Protective Shield (FDA Code: KPY / 892.6500) A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

• Pillow

• Positioning Systems, Headrests

• Powered Medical Examination Table (FDA Code: LGX / 878.4960)

• Protective Apron (FDA Code: IWO / 892.6500)

• Protective Restraint (FDA Code: FMQ / 880.6760) A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.

• Radiographic Head Holder (FDA Code: IWY / 892.1920) A radiographic head holder is a device intended to position the patient's head during a radiographic procedure.

• Radiologic Patient Cradle (FDA Code: KXH / 892.1830) A radiologic patient cradle is a support device intended to be used for rotational positioning about the longitudinal axis of a patient during radiologic procedures.

• Radiologic Table (FDA Code: KXJ / 892.1980) A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.

• Specialty Magnetic Resonance Coil (FDA Code: MOS / 892.1000) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

• Sterile Absorbent Tipped Applicator (FDA Code: KXG / 880.6025)

• Sterile Surgical Drapes (FDA Code: KKX / 878.4370)