Profile: Velcromex, S.A. De C.V. is engaged in the production of carpal tunnel wrist splint, cold pack wrap, convertible headgear, fetal monitor belt and headstrap accessory for operating headlamp, ice bag and patient support straps. We also supply phototherapy mask positioning straps, pressure applying device, shoulder orthosis, surgical tubing strap, tracheostomy tube holder, walker or gait training belts and wheelchair belt.
FDA Registration Number: 9680215
US Agent: Keitha.barritt,esq. / Fish & Richardson P.c.
Phone: +1-(202)-783- Fax: +1-(202)-783- E-Mail:
21 Products/Services (Click for related suppliers)
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• AC-Powered Operating Headlamp (FDA Code: HPQ / 886.4335) An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures. |
• Breathing Tube Support (FDA Code: JAY / 868.5280) A breathing tube support is a device that is intended to support and anchor a patient's breathing tube(s). |
• Cervical Orthosis (FDA Code: IQK / 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. |
• Endoscopic Prescription Lens Eyepiece (FDA Code: FDZ / 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. |
• Foley Catheter Holders (FDA Code: EYJ / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use). |
• Gas Mask Head Strap (FDA Code: BTK / 868.5560) A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face. |
• Hand Splint and Component (FDA Code: ILH / 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. |
• Hot & Cold Therapy Products, Cold Pack Wraps |
• Limb Brace Orthosis (FDA Code: IQI / 890.3475) |
• Oxygen Masks (FDA Code: BYG / 868.5580) An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. |
• Patient Position Support (FDA Code: CCX / 868.6820) A patient position support is a device intended to maintain the position of an anesthetized patient during surgery. |
• Perinatal Monitoring System (FDA Code: HGM / 884.2740) A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts. |
• Pressure Applying Device (FDA Code: KNM / 890.5765) A presssure-applying device is a device intended for medical purposes to apply continuous pressure to the paravertebral tissues for muscular relaxation and neuro-inhibition. It consists of a table with an adjustable overhead weight that, in place of the therapist's hands, presses on the back of a prone patient. |
• Shortwave Diathermy for use in Applying Therapeutic Deep Heat (FDA Code: IMJ / 890.5290) A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radio frequency bands of 13 megahertz to 27.12 megahertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. |
• Table Operating Room Accessories (FDA Code: FWZ / 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. |
• Therapeutic Medical Binder (FDA Code: MDR / 880.5160) A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder. |
• Tracheal Tube Fixation Device (FDA Code: CBH / 868.5770) A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings. |
• Tracheostomy Tube Holders |
• Transfer Aid (FDA Code: IKX / 890.5050) A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function. |
• Transfer Aid for Disabled/Handicapped (FDA Code: IKX / 890.5050) |
• Ureteral Catheter Holder (FDA Code: EYJ / 876.5130) |