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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
Ki Mobility LLC
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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K Number
K201869Device Name
Ki Power Tilt System
Manufacturer
Ki Mobility LLC
Date Cleared
2023-09-05
(1155 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Ki Mobility LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ki Mobility Power Tilt System kit design is intended for use on a manual wheelchair to provide patients with posterior tilt for positioning and seating pressure relief.
Device Description
The Ki Power Tilt System is an assembly that can be used to provide powered tilt on a manual wheelchair. It is an option for the Focus CR manual wheelchair to allow user control of the seating tilt angle. The system uses a battery operated motor gear drive connected between the base frame and the rotational seat tilt frame. A curved gear rack is coupled to the rocker frame and driven by the motor gearbox to control tilt motion. The user controls tilt using a toggle switch or hand pendant control connected to the motor control box. Adaptive switches, such as head arrays, may be connected to an interface control box that connects to the control box. An external battery charger is provided to charge the system. The motor control system uses a soft start/soft stop for ramping down the motor speed with a current limit to momentarily shut down power supply to the motor. End of travel in the tilt range will engage the current limit and the Focus CR Tilt Stops can be used to limit the tilt range from the unrestricted range of 0° to 50°.
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K Number
K223527Device Name
Little Wave Clik, Rogue XP, Little Wave XP, Spark
Manufacturer
Ki Mobility LLC
Date Cleared
2023-08-31
(281 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
Ki Mobility LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ki Mobility Little Wave Clik, Rogue XP, and Spark manual wheelchairs are intended to provide mobility to pediatrics limited to a seating position.
Device Description
The Ki Mobility Little Wave Clik manual wheelchair is intended to provide mobility to pediatrics restricted to a sitting position. The Little Wave Clik manual wheelchair can be self-propelled by the occupant with access to hand-rims on the rear wheels or moved by an attendant with access to push handles. It is a rigid frame wheelchair wight capacity for all models of 165 pounds/75 kg. The Little Wave Clik wheelchair has a welded tubular high strength 1.125″ aluminum frame with bend/trim configurations that vary the seat angle, knee angle, front and rear seat heights, seat depth, and caster wing offsets provide more room for the user's legs without increasing the frame length or reducing seat support.
The seat frame is dimpled to create a consistent array for frame mounted components in 0.25" increments. An adjustable clamp is used to set the rear wheel center of gravity position relative to the backrest. A set of clamps and an aluminum cross tube comprise an adjustable cross strut to seat width. The strut position may be adjusted for optimal positioning for rigidity for rigidity for rigidity for rigidity for rigi any given seat depth. The front caster mount also contains a button to mate with dimples along the front tubes for vertical caster adjustment.
The Little Wave Clik has several components intended to grow with the pediatric user either with built in adjustment, or growth kits of separate parts. The Clik cross tubes come in growth kits with multiple accommodated chair widths. Growth of the chair is also accommodated from footplates that can handle multiple widths and are adjustable to fit footrest length.
The Little Wave Clik manual wheelchair has a folding backrest frame for ease of storage and transport. It utilizes discrete holes to adjust the backrest angle relative to the seat tube. It also utilizes an adjustable position backrest to adjust the seat depth.
The tubular aluminum frame accommodates both seat slings and removable depth adjustable aluminum seat pans that have overlapping portions that can grow in depth. The pans and slings are with wheechair seat cushions. The backrest frame accommodates either back upholstery or planar/contoured wheelchair backrests. For adjustable back upholstery has straps that accommodate multiple seat widths. Seat pans and slings have overlapping portions that can grow in depth. The frame is also designed to accommodate aftermarket seating.
The seat cushion is a separate medical device adapted for use to the Little primary contact surface to the occupant along with the backrest upholstery. Little Wave Clik components such as amrests will also have contact to the occupant. The chair may be used as a seat in a motor vehicle and conforms to ISO 7176-19:2022 as well as ANSI/RESNA WC-4 Section 19: 2017 requirements. Two sets of transit tie down loops are bolted to the frame.
The Clik XP and Clik XPe order forms are order form variations of the same device to meet different market's requirements for pricing and reimbursement. All can be configured identically.
The Ki Mobility Rogue XP manual wheelchair is intended to provide mobility to pediatics restricted to a sitting position. The Rogue XP manual wheelchair an be self-propelled by the occupant with access to hand-rims on the rear wheels or moved by an attendant with access to push handles. It is a rigid frame wheelchair with a standard weight capacity for all models of 200 pounds/91 kg. The Rogue XP wheelchair has a welded tubular high strength 1.375" aluminum frame with bend/trim configurations that vary the seat angle, knee angle, front and rear seat heights, seat depth. Taper frames provide additional positioning of user's legs without the use of other components or accessories.
The Roque XP frame has an index of holes for mounting the backrest. Additional hole can be provided behind the backrest to accommodate adjustable clamp is used to set the rear wheel center of gravity position relative to the backrest. The chair utilizes a welded cross strut to maximize the rigidity of the chair. The Rogue XP has a welded caster wing for stiffness with a knuckle housing. An internal pinion allows adjustment of caster and backwards. The caster mount takes multiple fork and caster types, including a +3/4" stem option.
The Rogue XP has several components intended to grow with the pediatric user either with built in adjustment, or growth kits of separate parts. The cross tube weldment is split in the can grow the chair up to 3 inches in width the rigidizer bar on the backrest has a similar split with insert to grow the width of the chair is also accommodated from footplates that can handle multiple widths and are adjustable to fit footrest length.
The Rogue XP manual wheelchair has a folding backrest frame for ease of storage and transport. It utilizes discrete holes the backrest angle relative to the seat tube.
The tubular aluminum frame accommodates both seat slings and removable aluminum seat pans. The pans and slings are available for use with wheelchair seat cushions by adherence view AB tape. The backrest frame accommodates either back upholstery or planar/ contoured wheelchair backrests. For adjustable back upholstery has straps that accommodate multiple seat widths. The frame is also designed to accommodate aftermarket seating.
The seat cushion is a separate medical device adapted for use to the Rogue XP and is the primary contact surface to the occupant along with the backrest upholstery. Rogue XP components such as armrests will also have contact to the occupant.
The chair may be used as a seat in a motor vehicle and conforms to ISO 7176-19:2022 as well as ANSJ/RESNA WC-4 Section 19: 2017 requirements. Two sets of transit tie down loops are bolted to the frame.
The Rogue XP, Rogue XPe and Rogue XP TTL order form variations of the same device to meet different market's requirements for pricing and reimbursement. All can be configured identically.
The Ki Mobility Little Wave XP manual wheelchair is intended to provide mobility to pediatics restricted to a sitting position. The Little Wave XP manual wheelchair can be self-propelled by the occupant with access to hand-rims on the rear wheels or moved by an attendant with access to push handles. It is a rigid frame wheelchair with a standard weight capacity for all models of 165 pounds/75 kg. The Little Wave XP wheelchair has a welded tubular high strength 1.375″ aluminum frame with bend/trim configurations that vary the seat angle, knee angle, front and rear seat heights, seat depth, and front frame provide additional positioning of user's legs without the use of other components or accessories.
The Little Wave XP frame has an index of holes for mounting the backrest. Additional holes can be provided behind the backrest to accommodate adjustable depth. An adjustable clamp is used to set the rear wheel center of gravity position relative to the backrest. The chair utilizes a welded cross strut to main . The front caster mount is a two-part system with a clamp embedded that allows adjustment of caster angle front to back. The caster mount takes multiple fork and caster types, including a +3/4" stem option.
The Little Wave XP has several components intended to grow with the pediatric user either with built in adjustment, or growth kits of separate parts. The cross-tube weldment is split in the center with an insert that up to 3 inches in width. The rigidizer bar on the backrest has a similar split with insert to grow the chair. Growth of the chair is also accommodated from footplates that can handle multiple widths and are adjustable to fit footrest length.
The Little Wave XP manual wheelchair has a folding backrest frame for ease of storage and transport. It utilizes discrete holes to adjust the backrest angle relative to the seat tube.
The tubular aluminum frame accommodates both seat slings and removable aluminum seat pars. The pans and shor use with wheelchair seat cushions by adherence via AB tape. The backrest frame accommodates either back upholstery or planar/ contoured wheelchair backrests. For adjustment, the tension adjustable back upholstery has straps that accommodate multiple seat widths. The frame is also designed to accommodate aftermarket seating.
The seat cushion is a separate medical device adapted for use to the primary contact surface to the occupant along with the backrest upholstery. Little Wave XP components such as armrests will also have contact to the occupant.
The chair may be used as a seat in a motor vehicle and conforms to ISO 7176-19: 2022 as well as ANSI/RESNA WC-4 Section 19: 2017 requirements. Two sets of transit tie down loops are bolted to the frame. All available options and accessories are listed on the order form in the labeling section of this submission. The Ki Mobility Spark manual wheelchair is intended to provide mobility to pediatics restricted to a sitting position. The Spark manual wheelchair can be self-propelled by the occupant with access to handrims on the rear wheels or moved by an attendant with access to push handles. It is a folding frame wheelchair with a standard weight capacity for all models of 165 pounds/75 kg.
The Spark wheelchair has a welded tubular high strength aluminum frame with configurations that vary the front and rear seat heights, seat depth, rear wheel position and caster housing position. A width adjustable cross brace connects the wheelchair side frames and allows for folding of the frame for storage.
The Spark has several components intended to grow with built in adjustment within a range of its initial configuration. Arm rests offer multiple options, including a pediatric t-arm with integrated side guard, standard thatable locking extendable flip up arm rests and tubular flip up arm rests. Footplates can handle multiple widths and are adjustable to fit footrest length.
The tubular aluminum frame accommodates aluminum seat pans for use with wheelchair seat cushions. The frame is designed to accommodate aftermarket seating systems.
The Spark manual wheelchair has a folding backrest frame for ease of storage and transport. It utilizes discrete holes the backrest angle relative to the seat tube and to adjust the seat depth.
Seat cushions and backrests are separate medical devices and are primary contact surfaces to the occupants such as armrests and footrests will also have contact to the occupant.
The chair may be used as a seat in a motor vehicle and conforms to ISO 7176-19:2022 as well as ANSI/RESNA WC-4 Section 19: 2017 requirements. Two sets of transit tie down loops are bolted to the frame.
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K Number
K223533Device Name
Little Wave Arc; Little Wave Flip
Manufacturer
Ki Mobility LLC
Date Cleared
2023-08-31
(281 days)
Product Code
LBE
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
Ki Mobility LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ki Mobility Little Wave Arc and Little Wave Flip manual wheelchairs are intended to provide mobility to pediatrics limited to a seating position.
Device Description
The Ki Mobility Little Wave Arc is used by pediatrics up to 165lb (75kg) in need of manual wheeled mobility offering an operator adjustable body support system. Angular repositioning of the occupant alters the seated pressure distribution to reduce potential of pressure ulcers, improve comfort, facilitate improved transfer and for improved daily activities such as eating, breathing and social interaction. The Little Wave Arc offers a tilting seat frame that tilts up to 45°, reclining backrest that recline up to 60°, and elevating leg rest, all adjustable by an attendant.
The Ki Mobility Little Wave Flip is used by pediatrics up to 165lb (75kg) in need of manual wheeled mobility offering an operator adjustable body support system. Angular repositioning of the occupant alters the distribution to reduce potential of pressure ulcers, improve comfort, facilitate improved transfer and for improved daily activities such as ocial interaction. The Little Wave Flip offers a tilting seat frame that tilts up to 45°, reclining backrest that recline up to 60°, and elevating leg rest, all adjustable by an attendant.
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K Number
K062660Device Name
CATALYSY
Manufacturer
KI MOBILITY LLC
Date Cleared
2006-10-24
(47 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
KI MOBILITY LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Catalyst wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position.
Device Description
The Catalyst is a traditional folding cross-brace wheelchair. It is made of lightweight aluminum tubing similar to what is used on existing products. The frame utilizes two cross tube sets and, when opened, nestles inside of the frame onto 4 hooks to create a box like rigid assembly. Upon the outside of this framework, and to the rear, are assembled 2 machined aluminum axle plates. Stainless steel receivers are mounted within the axle plates. Wheels of varying size and type are connected to the receivers via stainless steel axles. On the front end of the frame are assembled 2 aluminum housings. Caster forks are mounted to these housings via stainless steel axles. A variety of caster wheels and tires are then connected to the forks. Upon the top of the frame is attached a seat sling. Into the rear of the frame assembly 2 backtubes are inserted to the desired height. Backrest upholstery is affixed to the backtubes. Armrests receivers bolt onto the rear of each side frame. Individual Swing Away tubular arms are then inserted into the receivers. If flipback armrests are chosen a receiver is mounted onto the from of each side frame to catch the forward most section of the arm and the rear mounting is pivoting to allow the arm to rotate backward. Height Adjustable arms fit into a receiver that mounts onto the outside of the frame. Wheel locks mount onto the upper side frame and are adjusted so that the brake arm engages with the tire and when in the locked position prevents to the wheel from rotating. Swing Away footrests with footplates and heel loops attach at the front of the chair. There is a plug at the top of the footrest hanger that inserts into an opening at the top front of the wheelchair frame. The footrest hanger is turned 90 degrees away from the frame. Hold the latch, which is midway down the hanger, tightly against the front of the frame and rotate the footrest back towards center. The latch will engage once the footrest hanger is centered.
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