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510(k) Data Aggregation
K Number
K251707Device Name
IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
Manufacturer
Shenzhen Huachuangtong Industrial Co., Ltd.
Date Cleared
2025-08-01
(59 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Huachuangtong **Industrial **Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K232112Device Name
R&G Surgical Mask
Manufacturer
R&G Seguridad e Higiene Industrial S.A.C.
Date Cleared
2024-04-02
(263 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
R&G Seguridad e Higiene **Industrial **S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The R&G Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Device Description
The R&G surgical mask is a single-use, three-layer, flat-pleated surgical mask with ear loops and nosepiece. The mask is made of three layers, the inner layer is made of white polypropylene nonwoven fabric, the outer layer is made of white polypropylene nonwoven fabrics, and the middle layer is made of meltblown fabrics. The mask is held in place over the wearer's mouth and nose by two elastic ear loops welded to the mask. The elastic ear loops are made of 80% polypropylene + 20% spandex. The nose piece on the mask is to allow the user to adjust the mask around their nose and is made of 75% plastic + 25% wire. The R&G surgical mask will be supplied in white. The mask is sold unsterilized and is intended to be a single-use disposable device.
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K Number
K233667Device Name
Facial Toning device (UIC-189); Facial Toning device (UIC-589)
Manufacturer
Body Trim Industrial Co., Ltd
Date Cleared
2024-02-12
(89 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Body Trim **Industrial **Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Facial Toning device is intended to stimulate the face. The device is intended for cosmetic use.
Device Description
The Facial Toning devices, which come in two models (UIC-189, UIC-589), are intended for facial stimulation and are indicated for prescription cosmetic use. The anatomical site for application of the devices are the face.
UIC-189 is battery powered, has 4 output channels and has 4 operation programs.
UIC-589 is AC powered, has 10 output channels and has 4 operation programs.
The device is equipped with accessories of self-adhesive pads (cleared under K160081), electrode probes, electrode cables and adapters. All accessories, including self-adhesive pads, electrode probes, electrode cables and adapters can only be changed or replaced by a qualified person.
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K Number
K233035Device Name
Electronic Muscle Stimulator (Model MP01)
Manufacturer
Shenzhen Hengbosi Industrial Co., Ltd.
Date Cleared
2024-01-08
(105 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Hengbosi **Industrial **Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electronic Muscle Stimulator is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. Strengthening, toning and firming of arms and legs.
Device Description
Not Found
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K Number
K232797Device Name
Hygenix
Manufacturer
Shenzhen Hygenix Industrial Co., Ltd
Date Cleared
2023-12-11
(90 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Hygenix **Industrial **Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hygenix is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms. body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only.
Device Description
The Hygenix is a 3 Ply flat- pleated and Disposable surgical mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PC coated Aluminium wire. The model ear loop is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of Polyester and Spandex. The dimensions of the Mask are: length- 175 ± 5 mm and width- 95 ± 5 mm. These masks are single-use, disposable devices, provided non-sterile.
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K Number
K232008Device Name
Disposable Medical Examination Nitrile Gloves
Manufacturer
Raxwell Industrial LLC
Date Cleared
2023-08-08
(33 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Raxwell **Industrial **LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Device Description
Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove is in black color, non-sterile and can be available in six specifications: XS, S, M, L, XL, XXL. It meets all of the requirements of ASTM standard D6319-19.
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K Number
K231489Device Name
Sturdy Autoclave Super Microm
Manufacturer
Sturdy Industrial Co., Ltd
Date Cleared
2023-06-21
(29 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
Sturdy **Industrial **Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilized in the models SA-260MA and SA-260MA-R. The STURDY Autoclave Super Microm (models SA-260MA-R) is not recommended for sterilization of liquid intended for direct patient contact.
Device Description
The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is a table-top steam sterilizers that uses saturated steam at high pressures and temperatures and kills infectious bio-organisms. The steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to the established time, temperature, and pressure parameters. Items to be sterilized are placed in the sterilization chamber. The user selects a sterilization cycle, and presses the start switch to initiate the cycle. The sterilizer will automatically fill water into the chamber, heat the water into steam, introduce steam-flush and pressure-pulses, hold at a set pressure, temperature, and time to sterilize the items, and automatically vent the steam and cool the chamber down after the sterilization is complete.
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K Number
K231136Device Name
Fitness Belt (Model: KLT-07)
Manufacturer
Shenzhen KeLuTongDa Industrial Co.,Ltd.
Date Cleared
2023-06-16
(56 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen KeLuTongDa **Industrial **Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.
- The big belt is intended for use on the muscles in abdomen.
- The small belt is intended for use on the muscles in arms and thighs areas.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
Device Description
Fitness Belt (Model: KLT-07)
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K Number
K223329Device Name
Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
Manufacturer
Guangzhou Yongyi Industrial Co., Ltd.
Date Cleared
2023-05-26
(207 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Yongyi **Industrial **Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electric Breast Pumps are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
Device Description
The subject devices are intended to be used by lactating women to express and collect milk from their breasts. The devices are intended for a single user in the home environment or hospital setting. When properly connected, the pumping kit transfers the vacuum generated by the powered pump to the breast, enabling expression and collection of milk. A diaphragm in the backflow protection assembly physically isolates pump and tubing from the space where milk is expressed and collected, protecting the breast milk from contamination.
The Electric Breast Pumps contain 4 models, YY-A203, YY-A204 and YY-TC201. The YY-A46 model operates in single pumping mode only; models YY-A203, YY-A204 and YY-TC201 can be operated in single or double pumping modes. Models YY-A203 and YY-A204 have an LED panel and model YY-TC201 has an LCD panel to display working mode, cycle, timer, battery level, and Bluetooth symbol to user. While YY-A46 has an LED indicator to indicate the working status of the device, models YY-A46, YY-A203, and YY-A204 can be wirelessly operated via Bluetooth connection to a smart device. Users can select the working mode, adjust the suction level and cycle speed, and start or pause the device from a smart device. Model YY-TC201 can only be operated on the pump unit itself. All models have massage and expression mode and have a maximum working time of 30 minutes.
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K Number
K220657Device Name
Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)
Manufacturer
Zhejiang Rongsheng Industrial Co., Ltd.
Date Cleared
2023-02-10
(340 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Rongsheng **Industrial **Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medical Infrared Thermometer is a non-sterile. reusable clinical thermometer intended for the intermittent determination of human body temperature in no touch mode on the center of the forehead as the measurement site on people of one month and above.
Device Description
The Medical Infrared Thermometer is a non-contact, hand-held, battery powered device designed to measure human body temperature, which has the feature of simple and easy use, rapid measurement and accurate temperature feedback. The Medical Infrared Thermometer is an infrared thermometer to measure human body temperature using the infrared energy emitted in the area around the subject's forehead. The reference body site of the temperature measurement is axillary. The temperature measurement distance is 1-5 cm. The product is composed of enclosure, control panel, LCD screen, infrared sensor, PCB board, battery pack and USB charging inlet. The thermometer has three functions of digital LCD display, buzzer indication for measurement results and three color back light indication for temperature (32.0℃ to 37.3℃ with green back light; 37.4℃ to 38.0℃ with yellow back light; 38.1℃ to 43.0℃ with red back light). The device is powered by Li-ion Battery (3.7VDC; 30mAh), which can be recharged through a computer with USB port or by switching power supply (100-240V, 50/60Hz) connected with a USB charging cable. The switching power supply is not provided with the subject device and the USB charging cable will be provided with the subject device as an accessory. There are two models RST-TC59-1001 and RST-TC60-1001 included in this document. Both models share the same construction except differences on product structure including appearance of enclosure, PCB design, sensor, MCU and working condition (ambient temperature). There are three buttons on control panel of both models, the first button is for power on/off and temperature measurement function, the second button is for temperature unit shift (°C and °F) function, the third button is for memory function.
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