ICON Medical Imaging,
Rhodes Medical Instruments, Inc.,
Theratogs, Inc.,
more...
(FDA Code:
IRO /
890.5975)
Identification. A therapeutic vibrator is an electrically powered device intended for medical purposes that incorporates various kinds of pads and that is held in the hand or attached to the hand or to a table. It is intended for various uses, such as relaxing muscles and relieving minor aches and pains.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9.
Dynatronics Corporation,
Import Export Of Usa Llc,
Healthsonix Inc.,
more...
DM Systems, Inc,
Alimed, Inc.,
Engineering Fitness International, Inc.,
more...
3-Point Products, Inc.,
Alimed, Inc.,
Stellar Orthopedics, Inc.,
more...
Dynatronics Corporation,
Access Equipment Corp.,
H&w Distribution (Sensa Products),
more...
Hospital Marketing Services Co., Inc.,
BE Well USA, Inc,
Dynatronics Corporation,
more...
Pro Orthopedic Devices,
Royce Medical Company,
DJ Orthopedics Inc.,
more...
Thermography, thermal imaging, or thermal video, is a type of infrared imaging science. Thermographic cameras detect radiation in the infrared range of the electromagnetic spectrum (roughly 900-14,000 nanometers or 0.9-14 µm) and produce images of that radiation. Since infrared radiation is emitted by all objects based on their temperatures, according to the black body radiation law, thermography makes it possible to see one's environment with or without visible illumination. The amount of radiation emitted by an object increases with temperature, therefore thermography allows one to see variations in temperature. When viewed by thermographic camera, warm objects stand out well against cooler backgrounds; humans and other warm-blooded animals become easily visible against the environment, day or night. As a result, thermography's extensive use can historically be ascribed to the military and security services.Thermal imaging photography finds many other uses. For example, firefighters use it to see through smoke, find persons, and localize the base of a fire. With thermal imaging, power lines maintenance technicians locate overheating joints and parts, a telltale sign of their failure, to eliminate potential hazards. Thermal imaging cameras are also installed in some luxury cars to aid the driver. Some physiological activities, particularly responses, in human beings and other warm-blooded animals can also be monitored with thermographic imaging.
Access Equipment Corp.,
Proximus Medical Inc.,
STI Inc,
more...
Thermophore electric moist heating pad are used for treatment of back pain, arthritis and muscle spasms. It penetrates moist heat for deep, temporary pain relief. This pad includes a special flannel cover that retains moisture for deep tissue therapy. The hot therapy expands the size of the blood vessels, increasing blood flow. This pad is controlled by the patient with a momentary switch that can be turned off and on to maintain the highest temperature possible.
Anspach Effort, Inc.,
Zeppelin Medical Instruments Ltd.
VQ OrthoCare,
Hospital Marketing Services Co., Inc.,
BE Well USA, Inc,
more...
Thermoplastic thumb splint is useful in treating an incomplete tear or a strain of the ulnar collateral ligament of the thumb. It can be fabricated which holds the metacarpophalangeal joint in a neutral position. It gives close approximation of the ligament to the proximal phalanx and metacarpal so that healing can occur. It can be modified over time to allow for reduction in oedema thus maintaining correct fit and joint positioning.
Royce Medical Company,
DJ Orthopedics Inc.,
Innovative Medical Products, Inc,
more...
Bulow Orthotic & Prosthetic Solutions,
Corefit Orthotics,
Footstar Orthotics,
more...
Southwest Medical,
DJ Orthopedics Inc.,
Datascope Corp.,
more...
Pro Orthopedic Devices,
DJ Orthopedics Inc.,
Hospital Marketing Services Co., Inc.,
more...
(FDA Code:
IPT /
890.349)
Identification. 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.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.
Aspen Medical Products, Inc.,
Hospital Marketing Services Co., Inc.,
Medtronic Xomed Surgical Products, Inc,
more...
DJ Orthopedics Inc.,
Medical Gear For Life,
Zimmer, Inc.,
more...
Orthofix Inc.
(FDA Code:
JDW /
888.304)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Classification. Class II.
Sgarlato Labs,
Depuy Orthopaedics, Inc.,
Hand Biomechanics Lab, Inc.,
more...
Onyx Medical Corp.,
Narang Medical Limited
Orthofix Inc.
Pro Orthopedic Devices,
Alimed, Inc.,
Patterson Medical Products, Inc.,
more...
Pro Orthopedic Devices,
Royce Medical Company,
Mizuho OSI,
more...
Royce Medical Company,
Ita-med Co,
Medbarn.com,
more...
The thumb brace is designed to prevent injury to the thumb by backward or sideward movement. A common injury in skiing, the brace is also useful in ball sports. It measures under the knuckles and chooses left or right.
DMES, Inc.,
Hub4Health.com,
Medical Department Store,
more...
Royce Medical Company,
Sky Medical, Inc.,
Abbey International Enterprises,
more...
Thumb supports provide warmth and compression to reduce pain in the thumb and wrist. It helps to prevent overuse while allowing maximum hand function. It is available in a easy to pull on style or a wrap on with hook and loop closure.
iHealthDepot.com,
3-Point Products, Inc.,
BetterBraces.com,
more...
U.S.E Surgical Instruments
Compaq Ortho,
Narang Medical Limited,
Med Plus India,
more...
(FDA Code:
HSH /
888.359)
Identification. A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (888.3027).
Classification. Class II.
Centerpulse Orthopedics Inc.,
Zimmer Dental, Inc.,
Moximed, Inc.,
more...
Howmedica International Ltd,
Stryker Canada
Plus Orthopaedics,
Biomet, Inc,
Encore Medical Company
Innovative Medical Products, Inc
Tibial IM Nails features titanium-alloy for greater strength, flexibility & biocompatibility, cannulated for insertion over the guide wire and optional flexion/extension instruments for full knee extension before proximal locking.
Depuy Orthopaedics, Inc.,
Biomet, Inc,
Stryker,
more...
Tibial inserts are intended for use in total knee replacement surgery or patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.
Hayes Medical, Inc.,
Plus Orthopaedics,
Biomet, Inc,
more...
Wright Medical Technology, Inc.
DePuy Orthopaedics, Inc,
Advanced Orthopaedic Solutions, Inc.,
Compaq Ortho,
more...
A tibial prosthesis includes a tibial tray and a stem. The stem has a cylindrical section and a tapering section. Fins extend longitudinally from the proximal end to the distal end of the stem to track both the cylindrical and tapering portions. The tapering section of the stem is equal to about one third of its overall length, and defines the distal end of the stem. The fins are longitudinally placed about the stem exterior surface, and are generally parallel.
Innovative Medical Products, Inc,
Zimmer, Inc.,
Encore Medical Corporation,
more...
DePuy Orthopaedics, Inc,
Live Tissue Connect Technologies,
Zimmer (u.K.) Ltd.
Tibiocalcaneal arthrodesis nail is intended for use in tibio-talo-calcaneal arthrodesis including deformities of the hindfoot and the distal tibia. The standard length arthrodesis nail has a focal area of high strain adjacent to the proximal interlocking screw. It also has an increase in tensile strain along the posterior surface of the tibia at the level of the interlocking screw. The use of the standard length nail places the interlocking screw holes in an area of normally elevated strain in an arthrodesed ankle. The nail ending in the metaphysis of the tibia decreases the strain in the distal tibia, and may protect this region from the stress fractures.
Depuy Orthopaedics, Inc.,
Biomet, Inc
(FDA Code:
ILY /
890.55)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.
Classification. Class II (performance standards).
Cutera, Inc.,
Cardiomedics, Inc.,
Palomar Medical Technologies, Inc.,
more...
Biomet, Inc,
Arthrocare Corporation
Regen Biologics, Inc.,
Lifecell Corp.,
Smith & Nephew Orthopaedics
Titanium ankle arthrodesis system is usually inserted into the long bones for fixation of fractures, or the fixation of long bones that is surgically prepared for correction of deformity, or arthrodesis. It is mainly intended for tibiotalocalcaneal arthrodesis.
Depuy Orthopaedics, Inc.
Titanium cannulated screw is used for odontoid screw fixation and atlantoaxial transarticular screw fixation. It is made of titanium alloy. It provides protection for corrosion, and it has bio-compatibility, high strength, low modulus and density.
Depuy Orthopaedics, Inc.,
Stryker,
Encore Medical Corporation,
more...
DePuy Orthopaedics, Inc
Titanium carbon finger joint implants are used in finger joint replacement surgery. There are two types of finger joint implants that include MCP and PIP implants. MCP finger joint implants are designed to help people who need to have their knuckles, or metacarpophalangeal joints replaced. PIP implants are designed to replace the proximal interphalangeal (PIP) joints which lie between the first two bones of the finger. These implant helps patients regain as much natural function as possible in their fingers.
Wright Medical Technology, Inc.
Titanium carpal lunate implant has the same anatomical configuration as the lunate bone, the concavities being more pronounced to provide for stability. The implant has a pair of suture holes designed for use in suture fixation through the scaphoid and tr
Wright Medical Technology, Inc.
Titanium carpal scaphoid implants are designed to replace the carpal scaphiod bone. It improves stability and maintains joint space. It has a beak on the distal pole which fits under a shelf formed in the carpal trapezium or trapezoid bone, and a suture h
Wright Medical Technology, Inc.
Titanium interference screw is intended for tibial and femoral fixation of tendon grafts in anterior and posterior cruciate ligament reconstruction. It is composed of titanium, which is commonly used in medical devices for a wide range of application.
Stryker,
HIB Surgicals
Titanium internal fixation systems consist of implantable bone screws and specialized surgical instruments that are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot.
Depuy Orthopaedics, Inc.,
Metasurg,
Inor
