Search Results
Found 7 results
510(k) Data Aggregation
K Number
K213056Device Name
LED Facial Mask
Manufacturer
Shenzhen OSTO Technology Company Limited
Date Cleared
2022-07-07
(288 days)
Product Code
OLP, OHS
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen OSTO Technology Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LED Facial Mask is an over the counter device. The Red light mode is intended for the treatment of periorbital wrinkles. The Red and Infrared light combination mode is intented for the treatment of full-face wrinkles. The blue light is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.
Device Description
LED Facial Mask (Model: AST-804, AST-804A, AST-804B, AST-805, AST-805A, AST-805B)
Ask a Question
K Number
K211942Device Name
Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
Manufacturer
Shenzhen OSTO Technology Company Limited
Date Cleared
2021-12-13
(173 days)
Product Code
NGX, IRT, NUH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen OSTO Technology Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PMS(1 ~ 2): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS(3 ~ 5): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm and leg due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Heating: The Heating Lumbar Therapy Cushion is intended for temporary relief of minor aches and pains.
Device Description
The Heating Lumbar Therapy Cushion is a portable TENS/PMS device is equipped with a remote control, an adapter, a pair of electrode pads and electrode wire. The electrode wire is used to connect the electrode pads to the main unit.
The device has 5 stimulate modes and one heating mode, through the stainless steel plate to provide users with lower back stimulation and heat generation to warm and comfortable lower back muscles. In addition, it is equipped with a pair of electrode pads, which can be used to stimulate different parts of the body (the shoulder, waist, back, arm and leg).
The principle of operation of the subject device is:
PMS: A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. This device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.
TENS: The electrodes placed on the skin send small-scale, low-voltage electrical pulses to specific nerves. The purpose is to change the way neurons send signals and prevent pain signals from reaching the brain to relieve pain.
All the functions of the device can only be controlled by the remote control, which should connected to the main unit through a wire. The remote controller has the component of ON/OFF Key, Mode Selection key (left and right), Intensity Modification keys (increase and decrease) and an LCD screen. And the LCD screen can show stimulation mode, stimulation intensity, heating intensity and time remaining of an application mode. The device has 5 stimulation modes, each with 50 stimulation intensity and one heating Mode, heating mode has 3 levels, namely level 1 (37°C), level 2 (40°C), and level 3 (43°C).
The stainless steel plate provides users with lower back stimulation and heat to warm and comfort the muscles of the lower back. The stimulation function and heating function can be used separately or simultaneously. When used with a pair of electrode pads, it must be used simultaneously with the main unit stimulation mode, otherwise the electrode pads will be invalid.
The equipment has four models: AST-622, AST-622B, AST-623B, the four models differ only in appearance.
Ask a Question
K Number
K211736Device Name
Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
Manufacturer
Shenzhen OSTO Technology Company Limited
Date Cleared
2021-09-05
(90 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen OSTO Technology Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Device Description
Electronic Muscle Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.
Electronic Muscle Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.
The models AST-300A and AST-300W have 9 buttons which is more than other models. Compared with other models, the "Time+" and "Time-" buttons are used to adjust the treatment time.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application model. The device is equipped with accessories of electrode pads, electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device. The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
Ask a Question
K Number
K210756Device Name
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
Manufacturer
Shenzhen OSTO Technology Company Limited
Date Cleared
2021-06-11
(88 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen OSTO Technology Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg, due to strain from exercise or normal household and work activities.
- Neck Pad is used on back of neck.
- Meridian Pad is used on shoulder, waist, back, arm and leg.
Device Description
This instrument is a new generation of a household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low-frequency electronic therapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg. The main unit is used for the back of the neck and the streamlined ring design follows the physiological curvature of the human body. The Meridian Pad is used on the shoulder, waist, back, arm and leg.
The device has 2 operation modes: Stimulation and heating. The stimulation has 2 modes for stimulating, and 50 output Intensity Levels. The heating only has 1 mode for heating and 3 temperature levels. The device can give a certain electrical pulse through 2 pairs of electrode pads that are placed on the skin to help users to enjoy stimulation on the shoulder, waist, back, arm, and leg when using the individual Meridian pads or on the back of the neck when using the Neck Pad.
For Model AST-905A and AST-905H: The remote control of this device is user-friendly controlled because it has the operating elements of the ON/OFF button. left or right button, and increase or decrease button. The device is equipped with accessories of electrode pads and an electrode wire. The LCD display screen can show the selected mode, the stimulation, and the time remaining of an application mode. The device can be successfully opened only when both the switch button of the remote control and the main unit turned on. When the device connected to the remote control, the remote control is the only controller to select the pulse modes, temperature modes, pulse intensity, temperature levels and adjust the treatment time.
For Model AST-905D: The user can control the device effectively by the buttons on the main unit. There are 5 operation buttons: switch button, "M" button, ""C" button and "—" button. The switch button can help user to turn on/off the device, the "M" button intended to select the "C" button intended to select the temperature mode and the "-" button and "--" button intended to increase or decrease the Intensity Levels or temperature levels. The device is equipped with accessories of Meridian pads and an electrode wire.
Ask a Question
K Number
K190783Device Name
Health Expert Electronic Stimulator (model: AST-3000L)
Manufacturer
Shenzhen OSTO Technology Company Limited
Date Cleared
2020-03-14
(353 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen OSTO Technology Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
- TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Device Description
Health Expert Electronic Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.
Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.
The electronic stimulatory module has the operating elements of ON/OFF Switch, remote control ON/OFF key, Display screen, Heating adjust key, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The Heating adjust key can help user to select a temperature for warming sensation of the foot range 30 to 40 degree C, the superficial heating time is same as the treatment time you selected. The superficial heating and electrical stimulation can apply simultaneously or apply alternatively. The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the main unit; the adapter wire is used to connect the adapter to the device.
The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
Ask a Question
K Number
K190673Device Name
Health Expert Electronic Stimulator
Manufacturer
Shenzhen OSTO Technology Company Limited
Date Cleared
2019-12-12
(272 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen OSTO Technology Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Device Description
Health Expert Electronic Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.
Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.
The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
Ask a Question
K Number
K133929Device Name
HEALTH EXPERT ELCTRONIC STIMULATOR
Manufacturer
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
Date Cleared
2014-11-12
(324 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Device Description
Health Expert Electronic Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.
Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation, as well as certain non-electrical rolling massage through one massage roller.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.
The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
Ask a Question
Page 1 of 1