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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
Device Description
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K Number
K241041Device Name
Silver Fluoride Hypersensitivity Varnish
Manufacturer
Young Dental Manufacturing Co. 1, LLC
Date Cleared
2025-02-28
(318 days)
Product Code
PHR
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
Young Dental **Manufacturing **Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Young Silver Fluoride Hypersensitivity Varnish is indicated for the treatment of dental hypersensitivity in adults. It is intended for professional use only.
Device Description
Young Silver Fluoride Hypersensitivity Varnish is a formulation of silver, sodium fluoride, chitosan, acetic acid, and purified water intended for the treatment of dental hypersensitivity in adults. It is intended for professional use only.
Like other 510(k) cleared dental hypersensitivity varnishes including the predicate device, the proposed device works by physically occluding dentinal tubules through its silver and fluoride components. It contains small silver particles to facilitate their entry into the dentinal tubules, as well as chitosan and acetic acid to evenly disperse the solution. The product is supplied in a 10mL bottle with a dropper dispensing tip.
One to two drops of the varnish can treat up to 8 sites. If needed, a second application of the varnish may be administered after 1 week.
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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
K242578Device Name
EVOLVE Nitric Oxide Delivery System
Manufacturer
Mallinckrodt Manufacturing LLC
Date Cleared
2025-01-03
(127 days)
Product Code
MRN, MRP, MRQ
Regulation Number
868.5165Why did this record match?
Applicant Name (Manufacturer) :
Mallinckrodt **Manufacturing **LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Evolve DS (delivery system) delivers INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed Injector Module, which enables tracking of the gas delivery system waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with ventilators and respiratory care devices for which the Evolve DS has been validated. The Evolve DS provides continuous integrated monitoring of inspired NO2 and NO with a comprehensive alarm system. The Evolve DS also provides monitoring and alarms for the drug delivery system.
The Evolve DS incorporates a battery that provides up to 4 hours of uninterrupted NO delivery in the absence of external power. The Evolve DS also incorporates an integrated electronic blender that functions as a backup delivery device to provide an adjustable INOmax dose with user supplied oxygen to a manual resuscitator or gas delivery system. The electronic blender incorporates a separate control and delivery pathway that serves as a redundant mechanism for nitric oxide delivery in the event of a main system fault.
The Evolve DS must only be used in accordance with the indications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The Evolve DS is indicated for a maximum of 14 days use. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU), and secondary targeted clinical setting is the transport of neonates.
Device Description
The EVOLVE Nitric Oxide (NO) Delivery System (DS) is used for administration and monitoring of INOMAX (nitric oxide for inhalation). It is comprised of a main delivery device (EVOLVE), an electronic blender (eINOblender) for backup use, and a Cart which holds the EVOLVE as well as INOMAX drug cylinders, an oxygen cylinder and miscellaneous parts.
The EVOLVE Nitric Oxide Delivery System utilizes Technology component technology to deliver Nitric Oxide gas to the patient. The components consist of a main delivery device (EVOLVE), an electronic blender (eINOblender) for backup use, and a Cart which holds the EVOLVE as well as INOMAX drug cylinders, an oxygen cylinder and miscellaneous parts. In this revision of the EVOLVE Nitric Oxide Delivery System, the changes to the device includes the labeling for compatibility with respiratory care devices.
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K Number
K242346Device Name
Grass® MR Conditional/CT Cup Electrodes
Manufacturer
Natus Manufacturing Limited
Date Cleared
2024-08-29
(22 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
Natus **Manufacturing **Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Grass MR Conditional/CT Cup Electrodes and Arrays are intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording.
This device is non-sterile for Single Patient Use Only and may remain on the patient in an MRI or CT environment under specific conditions.
Device Description
Grass® MR Conditional/CT Cup Electrodes are for surface monitoring EEG, electromyogenic and physiologic data signals commonly recorded on the chest, extremities, head and faces of patients. Grass® MR Conditional/CT Array Cup Electrodes are also used in electrocardiography, evoked potentials, and polysomnography. The Grass® MR Conditional/CT Array Cup Electrodes are MR conditional/CT. The included extension cables are MR/CT Unsafe.
The Operating Principle and technological characteristics of the Grass MR Conditional Cup Electrodes are identical to the predicate device (K171102), with a few dimensional and material modifications that have been assessed to be equivalent to the predicate and therefore do not affect the fundamental scientific technology, safety, or effectiveness of the device (reference Substantial Equivalence of Technological Characteristics table, below). The test methods were identical to those used to assess the predicate device.
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K Number
K241754Device Name
NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate
Manufacturer
Zimmer Switzerland Manufacturing GmbH
Date Cleared
2024-08-15
(58 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Zimmer Switzerland **Manufacturing **GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NCB® Polyaxial Locking Plate System:
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of distal femoral (NCB DF), proximal humeral (NCB PH), and proximal tibial (NCB PT) fractures and osteotomies.
NCB® Periprosthetic Femur Plate System:
The NCB Periprosthetic Femur Plate System is indicated for temporary internal fixation and stabilization of femoral fractures and osteotomies, including periprosthetic fractures.
If combined with the NCB Periprosthetic Trochanter Plate and Connection Screw, the NCB Periprosthetic Proximal Femur Plate is additionally indicated for temporary internal fixation and stabilization of greater trochanter fractures and osteotomies including re-attachment of the greater trochanter following fracture and osteotomy in total hip arthroplasty.
The NCB Periprosthetic Trochanter Plate and Connection Screw can only be used in combination with the NCB Periprosthetic Proximal Femur Plate.
NCB® Cable Button:
The NCB Cable Button for the NCB Polyaxial Locking Plate System in combination with the Zimmer Biomet NCB Polyaxial Locking Plate System and Cable-Ready System Cerclage Cables is indicated for temporary internal fixation of fractures and osteotomies.
NCB® Straight Narrow Shaft Plate
The NCB Straight Narrow Shaft Plate is indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including periprosthetic fractures.
Device Description
NCB® Polyaxial Locking Plate System
The NCB (Non-Contact-Bridging) Polyaxial Locking Plate System is a plate solution intended for the treatures and osteotomies of the distal femur (NCB DF), proximal humerus (NCB PH) and proximal tibia (NCB PT). NCB plate holes allow for polyaxial screw placement (30° cone) with subsequent screw locking, the screws can act as lag screws and be used for fracture reduction. In the locked mode, the plates act as an internal fixator without contact between the plate and the risk of periosteal blood supply impairment.
An additional extension tuberculum minus plate can be assembled to the humeral plate with cerclage wire technique for fixation of anteroposterior (AP) tuberculum minus fractures. NCB femoral, humeral and tibial plates, cortical, cancellous and cannulated screws, locking cap, blind screw inserts and spacers are made from titanium alloy Protasul®-64 (Ti-6Al-4V - ISO 5832-3/ASTM F136). The tuberculum minus plate is made from cpTi (ISO 5832-2/ASTM F67), cortical screws from titanium alloy Protasul-100 (Ti-6Al-7Nb ISO 5832-11/ASTM F1295) and the cerclage wire from 1.4441 stainless steel Protasul-S (ISO 5832-1/ASTM F138-F139).
NCB® Periprosthetic Femur Plate System
The NCB (Non-Contact-Bridging) Periprosthetic Femur Plate System is a line of polyaxial locking plates for the treatment of femoral fractures, particularly of periprosthetic femoral fractures. The system consists of Proximal Femur Plates, Curved Shaft Plates, Trochanter Plates and a Connection Screw. The NCB System technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the locked mode the NCB Periprosthetic Plate acts as an internal fixator without contact between the bone suface, reducing the risk of periosteal blood supply impairment. This Non-Contact Bridging concept can be specifically controlled through the use of 1, 2, or 3 mm spacers, which are threaded into the plate holes prior to plate insertion.
Additionally, within this system, the NCB Periprosthetic Trochanter Plates used in combination with the NCB Periprosthetic Proximal Femur Plates for the treatment of proximal femoral fractures, which includes greater trochanter fractures and osteotomies. The Connection Screw for NCB Periprosthetic Trochanter Plate is used to attach the Proximal Femur Plate. The NCB Periprosthetic Trochanter Plates contain threaded conical holes which allow for monoaxial screw placement using locking screws with threaded heads. Non-locking cortical screws can also be used.
The NCB Periprosthetic Proximal Femur Plates are available in five lengths (Length=245mm, 324mm, 363mm, 401mm) which can be used either as standalone implants or in combination with the NCB Periprosthetic Trochanter Plates. The NCB Periprosthetic Proximal Femur Plate short (Length=115 mm) is used only in combination with the NCB Periprosthetic Trochanter Plates. The NCB Curved Shaft Plates are also included in the NCB Periprosthetic Femur Plate System and are specifically designed for the femur. The Proximal Femur Plates, Distal Femur Plates, Trochanter Plates and Connection Screw are made of a titanium alloy (Ti-6Al-4V (Protasul®-64WF) ISO 5832-3).
NCB Cable Button for NCB Polyaxial Locking Plate
The NCB (Non-Contact-Bridging) Cable Button for NCB Polyaxial Locking Plate is a temporary internal fixation component used in conjunction with Zimmer Biomet NCB Polyaxial Locking Plate System Cerclage Cables. The Cable Button is threaded into a vacant screw hole of the Zimmer Biomet NCB Polyaxial Locking Plate System and provides a positioning point for a Cerclage Cable.
The Cable Button is made of titanium alloy (Ti-6Al-4V (Protasul®-64WF) ISO 5832-3) and has a color anodization (Type III).
NCB Straight Narrow Shaft Plate
The NCB (Non-Contact-Bridging) Straight Narrow Shaft Plate is a line of polyaxial locking plates for the treatment of humeral and tibial shaft fractures, including periprosthetic fractures. The NCB System technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the locked mode the NCB Straight Narrow Shaft Plate acts as an internal fixator without contact between the plate and the risk of periosteal blood supply impairment. This Non-Contact-Bridging concept can be specifically controlled through the use of 1, 2, or 3 mm spacers, which are threaded into the plate holes prior to plate insertion.
The NCB Straight Narrow Shaft Plate is made of Titanium alloy [Ti6Al4V (Protasul®-64WF) ISO 5832-3].
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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
K241022Device Name
Sterile single use tip cleaner (WK800-S10 , WK800-S20)
Manufacturer
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
Date Cleared
2024-07-11
(87 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
WickiMed (Huizhou) Medical Equipment **Manufacturing **Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.
Device Description
The product has 2 sizes: 50mm(L)×50mm(W)×5mm(T) and 50mm(L)×25mm(W)× 5mm(T). The product is composed by a small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel' with a polyurethane foam base and pressure sensitive adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.
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K Number
K240910Device Name
EO Chex Indicator Tape
Manufacturer
Propper Manufacturing Co., Inc.
Date Cleared
2024-06-12
(71 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
Propper **Manufacturing **Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EO Chex Indicator Tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterlization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items.
The EO Chex indicator tape can be used in the following EO sterilization cycles:
1. 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure
2. 38°C, 759 mg/ L EO, 40-80% RH, 4.5 hours exposure
3. 54℃, 600 mg/ L EO, 40-60% RH, 45 min or longer
4. 55°C, 736 mg/ L EO, 40-80% RH, 1 hour exposure
5. 55°C, 759 mg/ L EO, 40-80% RH, 1 hour exposure
Device Description
The EO Chex "1" indicator tape is a single-use, beige color pressure-sensitive adhesive tape with pink stripes that can be used to secure packages for Ethylene Oxide Gas (EO) sterilization.
The pink stripes are process chemical indicators for monitoring of exposure to Ethylene Oxide sterilization. After sterilization exposure the pink stripes turn to orange-brown.
The EO Chex indicator tape is made in rolls ¾ inch and 1 inch wide and 55-60 yards long. Each roll has a core with 3-inch internal diameter that allows for use with any standard tape dispenser.
The indicator responds to the critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity, and concentration of Ethylene Oxide gas. During EO sterilization process indicator ink chemicals react forming an orange-brown compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve the required level, the indicator ink chemistry changes color from pink to orange-brown. If the parameters do not achieve the required level, the indicator color remains as any shade of pink.
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K Number
K240410Device Name
EVOLVE Nitric Oxide Delivery System
Manufacturer
Malinckrodt Manufacturing LLC
Date Cleared
2024-05-28
(106 days)
Product Code
MRN, MRP, MRQ
Regulation Number
868.5165Why did this record match?
Applicant Name (Manufacturer) :
Malinckrodt **Manufacturing **LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Evolve DS must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The Evolve DS is indicated for a maximum of 14 days use. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU), and secondary targeted clinical setting is the transport of neonates.
Device Description
The EVOLVE Nitric Oxide (NO) Delivery System (DS) is used for administration and monitoring of INOMAX (nitric oxide for inhalation). It is comprised of a main delivery device (EVOLVE), an electronic blender (eINOblender) for backup use, and a Cart which holds the EVOLVE as well as INOMAX drug cylinders, an oxygen cylinder and miscellaneous parts.
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