Search Results
Found 2728 results
510(k) Data Aggregation
(60 days)
Model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808:
Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes.
- The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation.
- The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
Model: INIA-ED001, INIA-ED002, INIA-BLD001, E1507:
Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes.
- The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation;
- The Photon mode: The red light is intended for the treatment of periorbital wrinkles.
Facial & Body Beauty Device is portable, non-sterile and reusable device, which is designed to achieve the aesthetic effect. The device mainly consists of a main unit and charging cable, and it is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the provided charging cable, but the device can not be used when charging.
The device is for home environment use, which has electrodes for microcurrent stimulation (the microcurrent stimulation mode was cleared under K252553) and light emitting diodes for light therapy treatment. Especially, the light therapy function of the device equips both red light (for wrinkles treatment) and blue light (for acne treatment) for model INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, while equips only red light for model INIA-ED001, INIA-ED002, INIA-BLD001, E1507.
To use the device, user should place the treatment head on the face and body (only applicable for microcurrent stimulation mode). The device will automatically shut down after treatment time is over.
N/A
Ask a specific question about this device
(72 days)
The Falco Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Falco Fusion System is designed to stabilize or fuse the sacroiliac (SI) joint, helping to reduce pain and improve mobility in patients suffering from SI joint disruptions or degenerative sacroiliitis. The system includes titanium alloy screws (Ti-6Al-4V ELI, ASTM F-136) in diameters of 11mm and 13mm, with lengths ranging from 35mm to 75mm. Additionally, the system comes with disposable Kirschner wires (316-LVM, ASTM F138) and reusable surgical (Stainless Steel, ASTM F899) instruments, providing a comprehensive solution for sacroiliac joint fusion procedures.
N/A
Ask a specific question about this device
(215 days)
The FreedomEdge® Syringe Infusion System consists of the following components:
- FreedomEdge® Infusion Pump
- Precision Flow Rate Tubing™
- High-Flo SubQ Needle Sets™
The FreedomEdge® Syringe Infusion System is indicated for use with the BD® 20 ml syringe (US Reference number: 302830), BD 30 ml syringe (US Reference number: 302832) and Hizentra® 20 ml prefilled syringe (NDC 44206-458-96).
For Immunoglobulin Administration:
The FreedomEdge Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins in the home, hospital, or ambulatory settings when administered according to the FDA approved biologic labeling:
- Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®);
- Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®)
- Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid 20ml Single-use pre-filled syringe (manufactured by CSL Behring®)
For EMPAVELI™ (pegcetacoplan) Administration:
The FreedomEdge Infusion System is specifically indicated for the subcutaneous infusion of EMPAVELI™ (pegcetacoplan) in the home, hospital, or ambulatory setting when administered according to the approved drug product labeling.
For RYSTIGGO® (rozanolixizumab-noli) Administration:
The FreedomEdge Infusion System is specifically indicated for the subcutaneous infusion of RYSTIGGO® (rozanolixizumab-noli) when administered according to the approved drug product labeling.
For Intravenous Antibiotic Administration:
The FreedomEdge Infusion Pump and Precision Flow Rate Tubing are specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling:
- Ertapenem, Meropenem, Oxacillin, and Tobramycin
The FreedomEdge Infusion System is a non-electrically powered, mechanical infusion system which is intended for subcutaneous or intravenous administration of drug products in a home, ambulatory, or clinical setting. The infusion system includes the FreedomEdge Infusion Pump, the High-Flo SubQ Needle Sets, and the Precision Flow Rate Tubing Sets. The infusion system is designed to be used with sterile, single use syringes (not manufactured or sold by Koru Medical Systems) as the drug reservoir. There have been no significant changes to the technological features (e.g., material, design, energy source, packaging, sterility, manufacturing method) since the previous clearance.
The fundamental operating principle of the FreedomEdge Infusion System is based on the Hagen-Poiseuille equation. The syringe containing the drug to be infused is connected to the flow rate control tubing and the subcutaneous needle set or venous access device and inserted into the pump. The syringe pusher of the pump applies a constant force to the plunger of the syringe. The infusion sets generate a defined amount of resistance which determines the flow rate. Flow rates are modeled using the Hagen-Poiseuille equation and verified at the boundary conditions for the system.
The design and operating principles of the system and its components have not been significantly modified since the device was first cleared. The same test methods were used as in prior submissions. Acceptance criteria were generated for Rystiggo using the same flow rate prediction model as used in prior submissions.
N/A
Ask a specific question about this device
(252 days)
The Flexicare FL-10000U Respiratory Humidifier is intended to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance via an endotracheal tube or face mask. For use by trained personnel only within a hospital/institutional environment. This device is intended to be used with the Flexicare Autofill Humidification Chamber and Flexicare Heated Wire Breathing Circuit.
FL-10000U is an electrically powered Respiratory Humidifier that actively conditions the inspired respiratory gases delivered to ventilated patients and those receiving respiratory support. It is used as part of a complete system including a Humidification Chamber and either a heated wire breathing system.
FL-10000U Respiratory Humidifier is used with patients who require mechanical ventilation or positive pressure breathing assistance via an endotracheal tube and/or face mask.
The heater plate warms the water in the Humidification Chamber installed on to the top of the device. Gases are warmed and gain humidity in the form of water vapor as they travel along the breathing circuit on the to the patient.
N/A
Ask a specific question about this device
(136 days)
The Fetal Doppler is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. The device is intended for use at or after 16 weeks gestation.
The Fetal Doppler U8-25, U9-25 is a handheld ultrasound device that employs the Doppler principle to detect the fetal heart rate (FHR) from a pregnant woman's abdomen.
The fetal doppler has a main unit and a probe. The main unit consists of main board, power module, battery, speaker and display screen. The probe integrated into the main unit consists of the ultrasonic transducers for signal transmission and reception. The ultrasonic signal is continuously transmitted at a frequency of 2.5 MHz.
The difference between U8-25 and U9-25 is their appearance. Except their appearances, there are no other differences between the fetal dopplers. They have the same intended use, power supply, and discharge holes close to a speaker.
N/A
Ask a specific question about this device
(30 days)
The FiberLocker® System is a single-use device intended to be used for reinforcement of the rotator cuff, following or during repair by suture or suture anchors, where weakness exists in the soft tissue.
The FiberLocker® System is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.
The FiberLocker System is comprised of two components: (1) the FiberLocker Implant (SpeedPatch PET) and (2) an instrument (FiberLocker Instrument) for fixation of said implant. The implant, a needled textile felt is made out of polyester staple fibers and is non-degradable. The FiberLocker Instrument, a surgical micro-stapling or felting device, is a sterile, single use device designed for the fixation of medical felt patches in soft tissue. The instrument can be powered by either the FiberLocker PowerUnit or the Powermax Elite Shaver.
N/A
Ask a specific question about this device
(86 days)
Feather/numiere 05 06 07 (05) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the decolletage.
Feather/ numiere 05 06 07 (Models: 05) is an over-the-counter light-emitting diode (LED) device that emits energy for the treatment of wrinkles. The device works by simultaneously emitting 630nm±10nm, 830nm ±10nm wavelengths for the treatment of wrinkles on the neck and decolletage (upper chest). The device is designed in a flexible silicone panel that contains red (630nm±10nm) and near infrared (830nm±10nm) light-emitting diodes (LEDs). The device also contains a controller that controls the power on and off of the device, and regulates the intensity of the treatment by pressing buttons, and the controller
N/A
Ask a specific question about this device
(36 days)
The FX CorAL hemodialyzers are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency, including pediatric patients.
Consider body and dialyzer surface area, blood flow, body weight and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.
The FX CorAL dialyzers are high-flux, single-use, steam-sterilized hemodialyzers. The dialyzers are provided blood pathway sterile and non-pyrogenic. The dialyzers allow for the transfer of water and solutes between blood and dialysate using semipermeable, hollow fiber membranes.
The FX CorAL dialyzers are high-flux, sterile devices designed for single-use acute and chronic hemodialysis. The dialyzers are configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzer. The dialyzers contain semipermeable membranes that allow for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer during hemodialysis. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.
N/A
Ask a specific question about this device
(76 days)
FemVue® Controlled Saline-Air Device is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
The FemVue® Controlled Saline-Air Device is a sterile dual-barrel contrast media syringe that is connected to an intrauterine catheter to instill saline-air contrast medium as part of a sono-hysterosalpingogram (Sono-HSG) procedure. Ultrasound of the fallopian tubes can be performed with or without assessment of the uterine cavity.
The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterile via ethylene oxide (EO) sterilization and is intended for single-use.
N/A
Ask a specific question about this device
(158 days)
FOP NM-10 is an ophthalmic non-mydriatic digital camera using iPhone SE3 which captures images of the fundus of the human eye and surface as well as surrounding areas of the human eye.
The FOP NM-10 is designed for imaging of the fundus and surface as well as surrounding area of the human eye, in a compact, portable format, with an inherent simplicity built in its operation and use. The application software (Remidio FOP) is loaded on top of the iOS operating system to enable the user to view, save, archive and retrieve the captured images of fundus and surface area of the human eye. It is a compact, battery-operated device that enables high-quality fundus photography without requiring pupil dilation. The device can be used in Hospitals and Ophthalmic clinics. The FOP NM-10 incorporates a 40° field of view (FOV) optical system optimized for high-resolution retinal imaging. The device employs infrared and white LED illumination to achieve adequate retinal illumination without causing discomfort to the patient. The device is built on a modular smartphone-based design, ensuring portability and ease of operation. The Remidio FOP app enables wireless control of illumination intensity, focus adjustments, capturing the images in Auto and manual modes, saving, editing and archiving images.
Physical Specifications
- a) Field of View: 40° (for a minimum pupil size of 3mm)
- b) Material: ABS, Silicone Rubber
- c) Diopter Correction: -16D to +16D
- d) Working Distance: 33mm
Output and Performance Characteristics
- a) Illumination (Light Source): Infrared LED and Cool White LED
- b) Camera Resolution: 64 line pairs per millimeter (lp/mm) (at the center)
- c) ISO Range: ISO 200 and 400
- d) Focus Adjustment: Manual and Tap to Focus
- e) Internal Fixation: 8 fixation points
- f) Operating temperature: 10° to 40°C
- g) Relative Humidity: 10% to 85%
- h) Atmospheric Pressure: 750 to 1060 hpa
N/A
Ask a specific question about this device
Page 1 of 273