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510(k) Data Aggregation
K Number
K243453Device Name
Philips Lumea IPL
Manufacturer
Philips Consumer Lifestyle B.V.
Date Cleared
2025-02-10
(95 days)
Product Code
OHT, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Philips Consumer Lifestyle B
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, 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.
Device Description
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K Number
K203383Device Name
Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62
Manufacturer
Philips Consumer Lifestyle - Innovation Site Eindhoven
Date Cleared
2020-12-15
(28 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Philips Consumer Lifestyle - Innovation Site Eindhoven
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Philips Avent double electric breast pump Advanced is intended to express and collect milk from the breast of a lactating woman, and to alleviate engorgement of the breast. The device is intended for a single user.
Device Description
The Philips Avent Double electric breast pump Advanced is intended to express and collect milk from the breast of a lactating woman. The device is intended for a single user. The subject devices are for repeated use by a single user and are for use in home and professional healthcare environments. The devices are not sterile. The subject devices are electrically powered double (Double Advanced) breast pumps consisting of the following key components: a motor unit with a press-button user interface, two expression kits with two milk collection containers connected with the motor unit via silicone tubes. The motor unit operates on embedded software. Software updates by end-users are not supported. The breast pump extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the nipple. The milk is collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, the expression kit includes a silicone diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on a rechargeable battery or on an external mains adapter that is provided with the system via a micro-USB type connection. The rechargeable battery can be charged from the external mains adapter if the motor unit is not in operation. The breast pump is provided with the same accessories as the predicate device (K201381), with the addition of a breast pump belt. The breast pump belt intended to carry the electrical breast pump while the device is used to express and collect milk. The belt is intended to be worn over clothes. The expression kit is provided in two types: cushion-type (SCF394/61) and flange-type (SCF394/62). The cushion-type expression kit has a silicone cushion which is mounted on the expression kit pump body. The cushion comes into contact with the breast for the duration of the expression session. In the flange-type expression kit, the silicone cushion is integrated in a rigid frame. This integrated part (flange) can be attached to the pump body with a screw connection. The silicone part comes into contact with the breast for the duration of the expression. The rigid frame is not in contact with the breast. All other components of the subject devices are not in contact with the breast.
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K Number
K201381Device Name
Philips Avent Single/Double electric breast pump Advanced
Manufacturer
Philips Consumer Lifestyle - Innovation Site Eindhoven
Date Cleared
2020-10-01
(128 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Philips Consumer Lifestyle - Innovation Site Eindhoven
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Philips Avent single/double electric breast pump Advanced is intended to express and collect milk from the breast of a lactating woman, and to alleviate engorgement of the breast. The device is intended for a single user.
Device Description
The Philips Avent Single/Double electric breast pump Advanced is intended to express and collect milk from the breast of a lactating woman. The device is intended for a single user.
The subject devices are for repeated use by a single user and are for use in home and professional healthcare environments. The devices are not sterile.
The subject devices are electrically powered single (Single Advanced) and double (Double Advanced) breast pumps consisting of the following key components: a motor unit with a press-button user interface, and expression kit with milk collection container (double pump: two kits and containers) connected with the motor unit via a silicone tube. The motor unit operates on embedded software. Software updates by end-users are not supported.
The breast pump extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, the expression kit includes a silicone diaphragm that physically separates the milk-contacting pathway from the vacuum system.
The motor unit operates on an external mains adapter that is provided with the system via a micro-USB type connection. Models SCF392 and SCF394 include a rechargeable battery that can be used for device operation. The rechargeable battery can be charged from the external mains adapter if the motor unit is not in operation.
The expression kit is provided in two types: cushion-type and flange-type.
The cushion-type expression kit has a silicone cushion which is mounted on the expression kit pump body. The cushion comes into contact with the breast for the expression session.
In the flange-type expression kit, the silicone cushion is integrated in a rigid frame. This integrated part (flange) can be attached to the pump body with a screw connection. The silicone part comes into contact with the breast for the duration of the expression. The rigid frame is not in contact with the breast.
All other components of the subject devices are not in contact with the breast.
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K Number
K161532Device Name
Philips Avent Comfort Single/Twin Electric Breast Pump
Manufacturer
Philips Consumer Lifestyle-Innovation Site Eindhoven
Date Cleared
2016-08-29
(88 days)
Product Code
HGX, POW
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Philips Consumer Lifestyle-Innovation Site Eindhoven
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Philips Avent Comfort Single/Twin Electric Breast Pump is intended to express and collect milk from the breast of a lactating woman. The device is intended for a single user.
Device Description
The subject devices are electrically powered single (Comfort Single) and double (Comfort Double) breast pumps consisting of a motor and pump body, press-button user interface, and collection kit. A vacuum pump creates a vacuum at the breast of the lactating woman. This vacuum is released after a short period of time. By repeating this behavior, a cyclic vacuum generation pattern is created which enables expressing of milk from the breast. The expressed milk will be collected in the container which can be used for storage. The breast pump supports different operating modes: stimulation, expression 1, expression 2 and expression 3. The stimulation mode is entered upon start of the device when suction is felt on the breast. Once the milk starts flowing an expression mode may be chosen that has the most comfort, e.g. the combination of rhythm and suction level.
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K Number
K151033Device Name
Philips Self-Adhesive Electrodes
Manufacturer
PHILIPS CONSUMER LIFESTYLE
Date Cleared
2015-07-28
(102 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS CONSUMER LIFESTYLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Philips Self-Adhesive Electrodes are intended for use with the PulseRelief device for applying Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscle Stimulation (EMS)
Device Description
The Philips Self-Adhesive Electrodes is used as a transcutaneous electrical nerve stimulation electrode in conjunction with the Philips PulseRelief device which is an electrical stimulator for TENS or EMS. Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device. It is composed of: 1. Metal target, 2. Rivet, 3. Textile adhesive layer, 4. Carbon layer, 5. Hydrogel layer, 6. Backing sheet. Proper current distribution is delivered via use of a printed silver pattern.
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K Number
K151035Device Name
PulseRelief
Manufacturer
PHILIPS CONSUMER LIFESTYLE
Date Cleared
2015-07-21
(95 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS CONSUMER LIFESTYLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OTC TENS/EMS stimulator PulseRelief is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
PulseRelief is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities and can be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Pulse Relief is designed to be used at home, by adults of all genders.
For Transcutaneous Electrical Nerve Stimulation (TENS) Self-adhesive electrodes are placed on the skin close to the area of pain. The device delivers pulses across the skin through these electrodes. This activates the underlying sensory nerves. The user can choose 15 pre-set TENS programs with different pulse settings. In each program, the intensity of the pulse can be adjusted.
For Electrical Muscle Stimulation (EMS). the electrodes are placed near the muscle to be stimulated. The device generates electrical pulses and passes these pulses across the surface of the skin to activate the underlying motor nerves. This makes the muscle contract. Contraction helps to condition the muscle in in order to facilitate performance.
The PulseRelief system consists of the following elements:
- Control unit with cable: generates the TENS/EMS pulses; connects to the 1st electrode; communicates with the mobile device; connects to the battery unit. The control unit has an on-off button.
- Battery unit: contains a battery and charging circuit; connects the 200 electrode to the control unit.
- Electrodes: Self-adhesive re-usable hydrogel electrodes with metal target plate for magnetic clamping to the control unit and battery unit.
- App on mobile device. The app controls the functions of the PulseRelief device via a Bluetooth Low Energy connection between the mobile device and the PulseRelief device.
- Adapter: for charging the battery unit via a micro-USB socket. To connect the USB-cable to the battery unit, the control unit needs to be disconnected.
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