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510(k) Data Aggregation
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(85 days)
The Pump In Style® Pro+ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The powered breast pump is intended for a single user. This breast pump is intended to be used in a home environment.
Pump In Style Pro+ is a powered breast pump intended to be used in a home environment (or similar such as an office). It features 2-Phase Expression technology, which runs pumping in two phases (Stimulation and Expression) by applying a cyclic negative pressure to mimic a baby's natural nursing rhythm.
Pump In Style Pro+ comprises a pump unit, which includes:
- User-adjustable controls: "On/Off" for powering on/off the device, "Let-down" for switching between pumping phases, and "Increase vacuum"/ "Decrease vacuum" for controlling vacuum intensity levels;
- a port for connection of the tubing that channels the vacuum;
- a port for connection of the power supply;
- an internal, non-replaceable, rechargeable lithium-ion battery providing users the option to power the breast pump without reliance on a wall-connection or external power source;
- a LED battery status indicator which informs users of available charge;
- a pump phase LED status indicator which informs users of the active pump phase;
- vacuum level LED indicators (total of 16, one for each vacuum level).
Pump In Style Pro+ is a double electric breast pump that can be used to extract breast milk from one breast at a time (i.e., single pumping) or from both breasts simultaneously (i.e., double pumping). A DC (direct current) motor is used to drive a membrane aggregate. This membrane aggregate creates the negative pressure (suction) required to extract the breast milk.
The materials of the milk-contacting components are compliant with 21 CFR 177 and 21 CFR 178.
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(57 days)
The CooperSurgical Milex™ pessaries are intended to provide support to pelvic organs when inserted in the vagina.
The following Indications for Use are associated with each of the following pessary styles:
Milex™ Incontinence Dish Pessaries and Incontinence Dish Pessaries with Support:
Incontinence dish pessary is indicated for use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women.
Milex™ Cube Pessaries and Cube Pessaries with Drainage Holes:
Cube pessary is indicated for nonsurgical management of pelvic organ prolapse in Stage III prolapse including rectocele and/or cystocele.
Milex™ Incontinence Dish Pessaries, Incontinence Dish Pessaries with Support, Cube Pessaries, and Cube Pessaries with Drainage Holes are intended for support to pelvic organs when inserted into the vagina. Milex™ Pessaries are made of silicone and distributed in a non-sterile condition. The Milex™ Pessaries are available in a variety of styles, each having a range of sizes. All pessaries are produced in a like fashion, utilizing injection molding of liquid silicone rubber. The Milex™ Pessaries are manufactured in pink for single patient use.
This submission includes the following designs of Milex™ Pessaries: Incontinence Dish Pessary (Dish without Support, Dish with Support) and Milex™ Cube Pessary (Cube without Drainage Holes, Cube with Drainage Holes).
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(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.
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(91 days)
The Paruu Wearable Breast Pump is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
The Paruu Wearable Breast Pump is a powered breast pump intended to be used by lactating women to express and collect milk from their breast in home healthcare environment. The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The breast milk is collected in a milk collector. The device consists of a pump motor (main unit), milk collection set (flange, diaphragm, duckbill valve, milk collector, flange cover) and accessories (flange insert, charging cable). The milk collection set and flange insert can be purchased separately.
The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The user interface consists of buttons allowing the user to switch between modes and control the vacuum pressure levels, and LED display that providing information on current mode, level, timer and battery status.
The device includes 23 different models, and based on their technological characteristics, are divided into two broad categories – P16 series consisting of models P16, P16-A, P16-B, P16-C, P16-D, and P20 series consisting of models P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D. The models within each series vary in terms of their external color. All device models include 4 working modes (Stimulation, Expression, Two-in-one and Dual frequency for P16 Series and Stimulation, Expression, Lactation, and Traction for P20 Series) and 12 suction levels for each mode.
To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on 3.7V rechargeable lithium battery. The rechargeable battery can be charged from the external power adapter (not included with the device) through the provided charging cable. All milk contacting components of the device are compliant with 21 CFR 177.
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