Guangzhou Fortunique Ltd.

Contact: Jane Campbell
Address: Block B 2, Zhou Shan Gang, Shi Bei Industrial Ave, Pan Yu Dist., Guangzhou 511410, China | Map/Directions >>

Profile: Guangzhou Fortunique Ltd. is a contract manufacturer of surgical and medical products. Our product line consists of arm slings, corrective shoe orthosis, disposable medical beds, surgical cameras, hand splints, handicapped canes, gas mask head straps, external brace knee joints and traction accessories. We also provide leg straps, skin pressure protectors, patient examination gowns and surgical sponges.

FDA Registration Number: 3003915904
US Agent: Shane Hubbs / Premier Guard, Llc
Phone: +1-(713)-861-7550 Fax: +1-(240)-250-7080 E-Mail:

38 Products/Services (Click for related suppliers)

• 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.

• 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.

• Bone Clamp (FDA Code: HXD / 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.

• 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.

• Cervical Orthosis (FDA Code: IQK / 890.3490)

• 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.

• 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.

• Disposable Medical Bed (FDA Code: KME / 880.6060)

Medical disposable bedding is a device intended for medical purposes to be used by one patient for a period of time and then discarded. This generic type of device may include disposable bedsheets, bedpads, pillows and pillowcases, blankets, emergency rescue blankets, or waterproof sheets.

• Disposable Suture Needle (FDA Code: GAB / 878.4800)

• Disposable/Reusable Surgical Suit (FDA Code: FXO / 878.4040)

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

• Examination Gown (FDA Code: FME / 880.6265)

An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination.

• 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 Knee Joint (FDA Code: ITQ / 890.3475)

• External Limb Component, Ankle/Foot (FDA Code: ISH / 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 Non-Inflatable Extremity Splint (FDA Code: FYH / 878.3910)

A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.

• 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)

• Handicapped Cane (FDA Code: IPS / 890.3075)

A cane is a device intended for medical purposes that is used to provide minimal weight support while walking. Examples of canes include the following: A standard cane, a forearm cane, and a cane with a tripod, quad, or retractable stud on the ground end.

• 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.

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

• Lumbosacral Orthosis (FDA Code: IPY / 890.3490)

• Mechanical Walker (FDA Code: ITJ / 890.3825)

A mechanical walker is a four-legged device with a metal frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance.

• 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.

• Patient Examination Gowns and Capes (FDA Code: FME / 880.6265)

• 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.

• Protective Barrier Cover (FDA Code: MMP / 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.

• Skin Pressure Protector (FDA Code: FMP / 880.6450)

A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).

• Sterile Arm Board with Cover (FDA Code: BTX / 878.3910)

• Surgical Apparel Accessories (FDA Code: LYU / 878.4040)

• Surgical Camera and Accessories (FDA Code: KQM / 878.4160)

A surgical camera and accessories is a device intended to be used to record operative procedures.

• Surgical Needle Guide (FDA Code: GDF / 878.4800)

• Surgical Sponge Counter (FDA Code: LWH / 880.2740)

A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.

• 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.

• 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.

• Traction Accessories (FDA Code: ILZ / 890.5925)

A traction accessory is a nonpowered accessory device intended for medical purposes to be used with powered traction equipment to aid in exerting therapeutic pulling forces on the patient's body. This generic type of device includes the pulley, strap, head halter, and pelvic belt.

• Traction Accessories, Leg Straps (FDA Code: ILZ / 890.5925)

• 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)