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510(k) Data Aggregation
K Number
K241374Device Name
Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)
Manufacturer
Anhui JBH Medical Apparatus Co., Ltd
Date Cleared
2025-02-28
(289 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Product Code :
IOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Manual Wheelchair is to provide mobility to persons limited to a sitting position.
Device Description
The S002, S004, S005, S006, S007, S008, S009 series are mechanical wheelchairs which are a manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to manoeuvre the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.
Main Components: Main frame, Backrest, Seat cushion, handgrip, front wheel, rear wheel, hand rim, crossbar, footrests, brake, Anti-tipper, Seat belt.
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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K Number
K243111Device Name
Bowhead ERA Wheelchairs
Manufacturer
Bowhead Design Corp.
Date Cleared
2025-01-10
(102 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Product Code :
IOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bowhead ERA Wheelchairs are manually operated wheelchairs intended to be used as a means of mobility for individuals restricted to a sitting position.
Device Description
The Bowhead ERA Wheelchairs are composite based mechanical, manually operated, wheelchairs intended to be used as a means of mobility for adults restricted to a sitting position. Using the push ring on the rear wheels, users can self-propel themselves forward or backwards. The chairs are designed for riding over various indoor and outdoor surfaces. The Bowhead ERA Wheelchairs include four (4) mechanical wheelchair models with each model containing slightly different design features. Each wheelchair is provided assembled with a sling backrest, seat, seat post, brakes, frame, rear wheels, and casters. The overall length, width and height, backrest angle, COG, wheelbase, and seat width and height are adjustable ensuring comfort for the patient.
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K Number
K242722Device Name
Manual Wheelchair (MASY23)
Manufacturer
Sichuan AST Medical Equipment Co., Ltd
Date Cleared
2024-11-22
(73 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Product Code :
IOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Manual Wheelchair is to provide mobility to persons limited to a sitting position.
Device Description
The MASY23 manual wheelchair is a mechanical wheelchair which is a manually operated, attendant and self-propelled transport device in a health care environment such as a hospital, nursing home or extended care facility. It is intended for medical purpose to provide mobility to persons limited to a sitting position. It can be folded for transport by bring two sides together.
The MASY23 Manual Wheelchair incorporates a main frame, a seat, two hand rims and four wheels. The wheelchair is designed with two small rear wheels and two gearing with hand rim, it can be manually moved forward and in reverse. The wheelchair can support users of up to 136 kg.
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K Number
K242560Device Name
Manual Wheelchair (SYIV100-CA9221)
Manufacturer
Foshan Shunkangda Medical Tech Co., Ltd.
Date Cleared
2024-10-24
(57 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Product Code :
IOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SYIV100-CA9221 manual wheelchair is to provide mobility to persons limited to a sitting position
Device Description
Not Found
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K Number
K241460Device Name
Manual Wheelchair
Manufacturer
Lichtmega Technology CO., Ltd.
Date Cleared
2024-07-11
(49 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Product Code :
IOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Manual Wheelchair is to provide mobility to persons limited to a sitting position.
Device Description
MW18 manual wheelchair is a mechanical which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a foldable frame, a seat, two footrests and four wheels. The larger rear wheels have push-rims of slightly smaller diameter projecting just beyond the user to manoeuvre the chair by pushing them on without requiring them to grasp the tyres. The manual wheelchairs have brakes that bear on the tyres of there are two push handles at the upper rear of the frame to allow for manual propulsion by a second person, e.g. caregiver. The wheelchair can support users of up to 120kg.
Main Components:
Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, hand rim, crossbar, footrest, skirt guard, brake, anti-tipper (optional)
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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K Number
K240120Device Name
Merlexi Craft Bariatric series of manual wheelchairs
Manufacturer
Turbo Wheelchair Co., Inc.
Date Cleared
2024-07-05
(171 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Product Code :
IOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Merlexi Craft Bariatric series of manual wheelchairs are intended for use to empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions for which manual wheelchairs are generally prescribed for use. In particular, the Merlexi Craft Bariatric wheelchairs are intended for users up to 425 pounds. They are not for MRI environment use.
Device Description
Not Found
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K Number
K232230Device Name
YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)
Manufacturer
Zhenjiang Assure Medical Equipment Co., Ltd.
Date Cleared
2023-10-03
(68 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Product Code :
IOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The YJ-K1/K2 Manual Wheelchair is to provide mobility to persons limited to a sitting position.
Device Description
The YJ- K1,K2 series are mechanical wheelchairs which are a manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to manoeuvre the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.
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K Number
K232198Device Name
Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF)
Manufacturer
Zhenjiang Assure Medical Equipment Co., Ltd.
Date Cleared
2023-09-15
(52 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Product Code :
IOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The YJ-011S Manual Wheelchair is to provide mobility to persons limited to a sitting position.
Device Description
The YJ-011S series is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bringing the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to maneuver the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.
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K Number
K232199Device Name
Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS; YJ-010B 20DFE;YJ-010B 20ADS; YJ-010B 20ADE; YJ-010B 20ADFS; YJ-010B 20ADFE; YJ-010B 22DS; YJ-010B 22DE; YJ-010B 22DFS;YJ-010B 22DFE; YJ-010B 22ADS;YJ-010B 22ADE; YJ-010B 22ADFS; YJ-010B 22ADFE; YJ-010B 24DS; YJ-010B 24DE; YJ-010B 24DFS; YJ-010B 24DFE; YJ-010B 24ADS; YJ-010B 24ADE; YJ-010B 22ADFS; YJ-010B 24ADFE)
Manufacturer
Zhenjiang Assure Medical Equipment Co., Ltd.
Date Cleared
2023-09-15
(52 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Product Code :
IOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The YJ-010B Manual Wheelchair is to provide mobility to persons limited to a sitting position.
Device Description
The YJ-010B series is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bringing the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footplates and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to maneuver the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.
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K Number
K200583Device Name
Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL
Manufacturer
Ki Mobility LLC
Date Cleared
2023-09-05
(1278 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Product Code :
IOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ki Mobility Focus CR manual wheelchair is a manually operated device with wheels that is intended to provide mobility to adults restricted to a sitting position.
Device Description
The Ki Mobility Focus CR manual wheelchair is intended to provide mobility to adults limited to a sitting position. The primary use is by adult users in need of manual wheeled mobility offering an operator adjustable body support system. The Focus CR offers both seat tilt and an optional reclining backrest, with both adjustable by the attendant.
The Focus CR manual wheelchair can be propelled by the occupant with access to hand-rims on the rear wheels or moved by an attendant with access to push handles are used by the attendant to control the seat tilt function and recline of the backrest. Hand control levers on the push handles or a foot-operated pedal on the frame are used to release a slide-locking mechanism for changing the seat tilt angle. The backrest recline is controlled through hand control levers on the push handles which release sliding mechanical wrapped spring rod locks to change the backrest angle.
The Focus CR wheelbase is of a welded high-strength aluminum frame, upon which an inner high-strength forged aluminum frame can rotate on four rollers (two on each side) fixed to the base frame. The use of two control paths rolling on the fixed rollers is designed to create a complex rotation (CR) with a neutral resting angle of 20° tilt and minimizes the translation of the user-loaded system weight for safely controlling the change in seat tilt angle. The high-strength tubular aluminum seat frame assembles to the inner rotating frame and can be adjusted for seat depth and to adjust the user loaded center of gravity (CG) relative to the frame. Seat adjustment is optimal when the user-loaded and unlocked seating system will rest without force applied at 20°. CG adjustment is made with two easily accessed bolts are align to a series of holes through the seat frame and connected to the inner rotating frame.
The Focus CR manual wheelchair has a folding backrest frame for ease of storage for transport. A non-folding backrest and a reclining backrest are options. The adjustable tubular aluminum seat and backrest frame assembly is made to adapt to planar seating systems which have hardware adapted to mount to tubes. A solid mounted and depth adjustable aluminum seat pan is available for use with wheelchair seat cushions and the backrest frame accepts contoured wheelchair backrests. The seating system is a separate medical device adapted for use to the Focus CR and is the primary contact surface to the occupant. Focus CR components such as armrests and footrests will also have contact to the occupant.
The Focus CR wheelchair is custom configured to the user requirements by order form selection of components and accessories. The standard weight capacity for all models is 300 pounds, with an option for configuration as a heavy-duty weight capacity of 400 lbs. The seat tilt range is -5° to 50° with an accessory tilt stop available to limit the range. The backrest recline option range is available from 0 to 65°, 10° to 75° or 20° to 85°. The Focus CR, CRe & TTL are the same product with order form variations to meet different market configuration requirements only for pricing.
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