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510(k) Data Aggregation
K Number
K251638Device Name
Mobility Scooter (MS160C)
Manufacturer
Suzhou Master Machinery Manufacturing Co., Ltd.
Date Cleared
2025-07-22
(54 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Suzhou **Master **Machinery Manufacturing Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position."
Device Description
The product is a Mobility Scooter which provides transport for the disabled and the elderly and to be used both indoors and outdoors.
This scooter is a battery powered four wheeled vehicle. It consists two Lead-acid batteries (in the battery box) with an off-board battery charger, frame, a seat, a back support, control panel (including the key switch, throttle control lever, horn button, speed adjustment dial, and the battery condition meter), two foldable handles, two rear drive wheels with motor/ e-magnetic brake components, two front wheels, anti-tip devices, an external battery charger, a control panel and a motor controller. For convenience of transportation and reduction of possible damage, the battery and the seat unit can be dismantled and separately packaged.
The front wheels of the scooter are 8 inches and the rear wheels are 9 inches.
The motor of the scooter is 24VDC,150W,4200RPM; the Lead-acid Battery is 12 V, 22 Ah, 18.7 Ah; the charger is 24V/2A.
Max. loading cannot be over than 180kg.
The maximum distance travelled with a fully charged battery is 17.5km and the maximum forward speed is 1.6m/s(5.8km/h).
Braking time is less than 2 seconds, braking distance is ≤1.0 meters.
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K Number
K242982Device Name
Mobility Scooter (MS160A)
Manufacturer
Suzhou Master Machinery Manufacturing Co., Ltd.
Date Cleared
2025-01-31
(127 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Suzhou **Master **Machinery Manufacturing Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Device Description
The subject device, Model MS160A scooter is mainly battery-powered and driven by a DC motor, with the speed adjusted by a user-controlled panel.
The motor is driven, and the speed is adjusted by a user-controlled panel and speed knob.
The scooter consists of two folding armrests, a seat cushion, a folding frame, two front wheels, two rear drive wheels with a motor/electromagnetic brake assembly, a rechargeable lithium-ion battery, an off-board battery charger, a control panel, and a motor controller.
The MS160A scooter is designed to provide mobility for people limited to those who walk unchanged or for the elderly.
Folding design: Pull out the seat and backrest fixing pins, push the backrest forward, the seat and backrest fold into each other, release the handlebar locking knob, push the handlebar backward, the handlebar folds down, the whole scooter is folded.
Control panel: Includes speed knob, battery gauge, power key switch, horn button, throttle control lever, headlight switch, charger port, fuse.
Wheel and frame connection method: the motor is connected to the differential, the differential is connected to the frame, the wheels are mounted on both ends of the differential, the motor rotates with the differential, thus driving the scooter.
Frame design:
1) The frame of MS160A is aluminum alloy.
2) The folding mechanism is operated in two ways:
a. In the non-riding state, pull out the seat fixing pin, push the backrest forward, the seat and backrest can be folded.
b. Loosen the handlebar locking knob, push the handlebar forward, the handlebar will fold down.
The front wheels of the scooter are 7 inches and the rear wheels are 10 inches.
The motor of the scooter is ST-62D24-120W; the lithium-ion battery is 25.55V 10.4AH; the charger is 24V/2A.
Max. loading cannot be over than 125kg.
The maximum distance travelled with a fully charged battery is 8.2km and the maximum forward speed is 1.8m/s.
Braking time is about 2 seconds, braking distance is ≤1.5 meters.
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K Number
K241463Device Name
Electric Wheelchair (MP201C); Electric Wheelchair (MP201L)
Manufacturer
Suzhou Master Machinery Manufacturing Co.,Ltd
Date Cleared
2024-07-18
(56 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Suzhou **Master **Machinery Manufacturing Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Device Description
This Electric Wheelchairs, modes!: MP201C, is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.
The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, seatbelt, pedal, battery box and charger.
The device is powered by Li-ion Battery pack with 24 Km range, which can be recharged by an offboard battery charger that can be plugged into an AC socket outlet (100-240V. 50/60Hz) when the device is not in use.
The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
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K Number
K240772Device Name
Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)
Manufacturer
Hunan Ceramaster Material Technology Co., Ltd
Date Cleared
2024-05-20
(60 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Hunan Cera**master **Material Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental Zirconia Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Device Description
Dental Zirconia Blank are derived from zirconia powder that has been processed into their final shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356, Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872. Dentistry - Ceramic materials.
Dental Zirconia Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank with the addition of very small amount of inorganic pigments before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
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K Number
K222711Device Name
HS186B Scooter
Manufacturer
Suzhou Master Machinery Manufacturing Co.,Ltd.
Date Cleared
2023-01-09
(123 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Suzhou **Master **Machinery Manufacturing Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Device Description
The subject device, Model HS186B Mobility Scooter, is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk but suffer from mobility limitations. It has a base with frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller, a control panel, an electric motor, an electromagnetic brake, a rechargeable Lithium-lon Battery with a charger. The movement of the scooter is controlled by the rider who operates the throttle Control Lever, speed knob and hand grips. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter is suitable for use indoors and on flat roads near buildings.
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K Number
K212914Device Name
Glovmaster Nitrile Examination Glove Powder Free
Manufacturer
Glovmaster SDN. BHD.
Date Cleared
2021-12-22
(100 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Glov**master **SDN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GLOVMASTER Nitrile Examination Glove Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
GLOVMASTER Nitrile Examination Glove Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.
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K Number
K191004Device Name
Advocate Non-Contact Infrared Thermometer
Manufacturer
BroadMaster Biotech, Corp.
Date Cleared
2019-09-05
(142 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Broad**Master **Biotech, Corp
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.
Device Description
The Advocate Non-Contact Infrared Thermometer, model EF001S, measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The device is composed of a Probe of metals with infrared sensor inside to detect the infrared energy, an LCD Display, a SCAN button to start measuring temperatures, a Power switch button to switch on or off the device, a Body/Ambient button to switch between two measuring modes, and an Enclosure of ABS. The device has the following features: one-second measuring time, measuring Body or Ambient temperature, 12-memory recalls, "F/"C unit switchable, over range message (Hi/Lo), low battery indication, auto display for the last reading when power is on, auto shut-off when the device is idle for 60 seconds and voice function.
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K Number
K180355Device Name
Advocate Non-Contact Infrared Thermometer
Manufacturer
BroadMaster Biotech, Corp.
Date Cleared
2019-01-10
(336 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Broad**Master **Biotech, Corp
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.
Device Description
The Advocate Non-Contact Infrared Thermometer model EF001A measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The device is composed of a Probe of metals with infrared sensor inside to detect the infrared energy, an LCD Display, a SCAN button to start measuring temperatures, a Power switch button to switch on or off the device, a Body/Ambient button to switch between two measuring modes, and an Enclosure of ABS.
The device has the following features: one-second measuring time, measuring Body or Ambient temperature, 12-memory recalls, 9F/℃ unit switchable, over range message (Hi/Lo), low battery indication, auto display for the last reading when power is on, and auto shut-off when the device is idle for 60 seconds.
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K Number
K171414Device Name
qEEG-Pro
Manufacturer
Brainmaster Technologies, Inc.
Date Cleared
2018-07-01
(412 days)
Product Code
OLU
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
Brain**master **Technologies, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The qEEG-Pro System is to be used by qualified clinical professionals for the statistical evaluation of the human electroencephalogram (EEG).
Device Description
qEEG Pro Database (QPD) is a software program for the post-hoc statistical analysis of the human electroencephalogram (EEG). EEG recorded on a separate device (i.e., the host system) is transferred to the QPD for display and user-review. The device herein described consists of a set of tables that represent the reference means and standard deviations for representative samples. These tables are implemented as computer files that provide access to the exact tabular data resource for use by software that uses the tables as an information resource. The system requires that the user select reliable samples of artifact-free, eyes-closed or eyes open, resting digital EEG for purposes of analysis.
Analysis consists of the Fast-Fourier Transformation (FFT) of the data to extract the spectral power for each of the designated frequency bands (e.g. delta, theta, alpha, and beta), and frequency information from the EEG. The results of this analysis are then displayed in statistical tables and topographical brain maps of absolute and relative power, power asymmetry, and coherence for 19 monopolar and 171 selected bipolar derivations of the EEG. In all over 5,000 measures are derived for comparison against carefully constructed and statistically controlled age-regressed, normative database in which the variables have been transformed and validated for their Gaussian distribution.
Each variable extracted by the analysis is compared to the database using parametric statistical procedures that express the differences between the patient and an appropriate age-matched reference group in the form of z-scores.
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K Number
K172963Device Name
Master-Frank N95 Particulate Respirator
Manufacturer
Master & Frank Enterprise Co., Ltd
Date Cleared
2018-04-04
(190 days)
Product Code
MSH
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
**Master **& Frank Enterprise Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The N95 Particulate Respirator (MF01) is single-use, disposable device, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Device Description
The N95 particulate respirator (Model MF-01) is NIOSH certified (TC-84A-7697), pouched-shaped respirators when worn. The flat-folded respirator is composed of four layers-inner layer, filter (2 layers) and outer layer. The four layers are combined via ultrasonically welded. The respirator also contains a nose-piece enclosed in a binding tape welding the top edge to conform to the contours of the face. The respirator contains straps to secure the respirator in place on the wearer. The respirator is offered in white. The respirator is provided non-sterile and for single use only.
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