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The PULLUP®, BT LOOP®, PULLUP® CLIP and PULLUP® TEX CLIP cortical fixation devices are indicated in adults for reconstruction of the anterior cruciate ligament. - PULLUP®, PULLUP® CLIP, PULLUP® TEX CLIP must be used with a Soft Tissue Transplant. - BT LOOP® must be used with a Bone Tendon Bone Transplant. The RIGIDLOOP™ T, RIGIDLOOP™ BTB, RIGIDLOOP™ Clip and RIGIDLOOP™ Suture Loop cortical fixation devices are indicated in adults for reconstruction of the anterior cruciate ligament. - RIGIDLOOP™ T, RIGIDLOOP™ Clip, RIGIDLOOP™ Suture Loop must be used with a Soft Tissue Transplant. - RIGIDLOOP™ BTB must be used with a Bone Tendon Bone Transplant.

- PULLUP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, and is designed to be used with a soft tissue graft. Standard and XL sizes. - BT LOOP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary split suture, and is designed to be used with a bone-tendon-bone graft. It is assembled on a holder that can be mounted on the GraftTech® preparation station. Standard and XL sizes. - PULLUP® CLIP: comprises a titanium button-plate only, is designed to be used with a soft tissue graft, and can either be connected to another PULLUP® CLIP button-plate by using the PULLUP® TEX CLIP nonabsorbable braided loop, or can be connected to another PULLUP® device. Standard and XL sizes. - PULLUP® TEX CLIP: Comprises a nonabsorbable braided loop. One size only. Standard models are used for cortical tunnels with a diameter of 4.5 mm; XL models are used for cortical tunnels with a diameter between 5 and 10 mm. The implants are supplied sterile, individually packaged, ready to use. The PULLUP®, PULLUP® CLIP, BT LOOP® and PULLUP® TEX CLIP devices are also sold under the trade names RIGIDLOOP™ T, RIGIDLOOP™ Clip, RIGIDLOOP™ BTB and RIGIDLOOP™ Suture Loop respectively.

SpO2 Extension Cables are intended to be used to connect SpO2 sensors, placed at appropriate sites on the patient to a monitoring device for SpO2 monitoring by health care professional.

SpO2 Extension Cable consists of two parts: the SpO2 patient cable and the adapter. The SpO2 patient cable is used for connecting the monitors, and the adapter is used for connecting the SpO2 patient cable and the SpO2 sensor. The SpO2 Extension Cable is the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors. By using the same types of construction and technological characteristics to the compatible patient monitor and SpO2 sensor, the SpO2 Extension Cable can avoid measured data corrupted. The proposed device was modification from the legally marketed (existing) device "SpO2 Extension Cable"/K222370, manufactured by "Beijing Rongrui-Century Science & Technology Co., Ltd.", same as the sponsor of this submission. Compared to the initial product (K222370), only the structure of the SpO2 Extension Cable has changed. Originally a non-separable complete extension cable, now an extension cable can be separated into two parts, called the SpO2 patient cable and the adapter. The type of instrument connector (which connects one end of the monitoring device) for the SpO2 patient cable is 20pin, there are four types pairing interfaces between SpO2 patient cable and adapter, the pairing interfaces name for the SpO2 patient cable and adapter connection is DB9F-LNCS, MLNCS-MLNCS, LNOP-LNOP, RD-RD and the other end of the adapter connecting to SpO2 sensor is DB9F. Adapters are divided into two categories: with cable and without cable. Adapters for each type of interface are available with and without cables.

The Portable Oxygen Concentrator P2-TOC is intended to provide supplemental low flow oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adults only.

The Portable Oxygen Concentrator P2-TOC is a device that uses the principle of molecular sieve pressure swing adsorption to increase oxygen concentration by adsorption of nitrogen and other gas components. The device needs to be used with a nasal oxygen cannula, which can provide oxygen supplementation to the user. The Portable Oxygen Concentrator P2-TOC has two oxygen supply modes, namely continuous oxygen supply mode and pulse oxygen supply mode. Hereinafter referred to as "continuous mode" and "pulse mode" . In the continuous mode, the Portable Oxygen Concentrator P2-TOC can continuously deliver oxygen at a fixed flow rate. In the pulse mode, the Portable Oxygen Concentrator P2-TOC is able to deliver oxygen only when the user inhales by detecting the human respiratory rate.

Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. Single use Syringe with or without Needle is intended to be used for medical purposes to inject fluid into or withdraw from body. Membrane Filter Syringe is intended to be used for medical purposes to inject fluid into or withdraw from body. The filter operates when injecting the human body to remove foreign substances from the drug solutions.

Single use Syringe with or without Needle consist of Syringe, Cap, Needle and Hub and Blister paper. Blister paper function to sustain sterilization of the product. The Cap function to protect the needle. This device is single use. This device is provided EO Sterilization, and the syringes of Luer Slip and Luer Lock. These devices are injecting the medicine with syringes. Biocompatibility testing and performance testing has been completed to support the substantial equivalence of the device.

MEN - The GroWell BT Hair Growth System ("GroWell") is designed to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of Ila to V. WOMEN - The GroWell is designed to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin classifications of I-II. The GroWell is approved for Fitzpatrick skin types I-IV.

The GroWell BT Hair Growth System consists of 24 proprietary red light diode lasers and 39 proprietary red light super-luminescent diodes configured in a flexible panel which is inserted in an adult, baseball-style cap. The GroWell contains 655nm laser and LED diodes, which generates light after being excited by the internal power supply, the light is controlled and output by the control device, and directly and effectively irradiated to the treatment site, so as to achieve therapeutic effect. The GroWell's conbination of diode lasers and non-laser LED's provides for a full coverage of the head: i.e, the scalp area roughly from the top of the head to the top of the ears. The GroWell session will be "paused" and the light array will automatically turn off if the user removes the GroWell during use, and will resume when it is replaced on the 25 minute session, the lights will turn off and the GroWell will emit two audible beeps to signal that the therapy is complete.

Air compression Leg Massager is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health, it can simulate kneading and stroking of tissues by using an inflatable garment.

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Over-The-Counter Use: TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, wast, back, arm,and leg, due to strain from exercise or normal household and work activities. EMS/NMES: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Prescription Use: TENS: 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; EMS/NMES: 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation; 3)Prevention or retardation of disuse atrophy; 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

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The Laser Speckle Imaging System (RFLSI CZW) is intended for blood flow measurements in the micro-circulation. This device is intended for clinical research use.

The Laser Speckle Imaging System (RFLSI CZW) is intended for blood flow measurements in the micro-circulation. This device is intended for clinical research use. It is a measurement tool based on the laser speckle contrast analysis technology and provides real-time blood perfusion information of tissue and organs in a visual and quantitative way. The device is non-patient contacting and does not require the use of contrast agents.

The Diode Laser Hair Removal System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

808nm diode laser using selective light absorption, the Diode 808 laser is preferentially absorbed by the melanin of the hair. The light energy is taken up by the hair follicle and converted to heat energy, and minimal energy is transferred to the skin. This preferentially heats the hair and its DNA, while reducing oxygen organization around hair follicle - reducing the chance of hair regrowth. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin. Diode Laser Hair Removal is the safest and fastest at the present. It adopts Gold standard 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. Meanwhile, don't hurt around tissues and virtually pain-free remove surplus hair; eventually, reach to permanent Hair Removal.