(281 days)
The Ki Mobility Little Wave Arc and Little Wave Flip manual wheelchairs are intended to provide mobility to pediatrics limited to a seating position.
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.
The provided document is a 510(k) Premarket Notification from the FDA for two manual wheelchairs, the "Little Wave Arc" and "Little Wave Flip." It focuses on demonstrating substantial equivalence to a legally marketed predicate device (R82 Kudu).
This document does not describe acceptance criteria for a medical device that relies on algorithms or AI assistance, nor does it detail a study proving such a device meets acceptance criteria. The devices in question are mechanical wheelchairs.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and the reported device performance for an AI/algorithmic device.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size with AI assistance.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The document instead focuses on non-clinical testing for mechanical wheelchairs against recognized consensus standards.
Here's the relevant information that is present in the document about the mechanical wheelchairs:
Acceptance Criteria and Study for Mechanical Wheelchairs:
The acceptance criteria for the "Little Wave Arc" and "Little Wave Flip" manual wheelchairs are implied by their successful testing against a series of recognized consensus standards for mechanical wheelchairs. The study described is a non-clinical testing summary.
-
Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria (Implied by Standards) Reported Device Performance (as stated in document) Compliance with ANSI/RESNA WC -4:2017 Section 19 (Wheelchairs in motor vehicles) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO-7176-1:2014 (Static stability) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-5:2008 (Dimensions, mass, maneuvering space) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-7:1998 (Seating and wheel dimensions) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-8:2014 (Static, impact, and fatigue strengths) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Specifically, the aluminum base frames have been "qualified through fatigue testing." Compliance with ISO 7176-11:2012 (Test Dummies) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-13:1989 (Coefficient of friction of test surfaces) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-15:1996 (Information disclosure documentation/labeling) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-16:2012 (Resistance to ignition of postural support devices) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-19:2022 (Wheeled mobility devices for use as seats in motor vehicles) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Compliance with ISO 7176-22:2014 (Set-up procedures) "Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Maintain intended function and safety (Overall) The non-clinical testing "exhibits that the device will perform as intended and risk analysis has documented risk reduction and identified requirements for labeling for safe and effective use of the device." -
Sample size used for the test set and the data provenance: Not applicable in the context of an AI/algorithmic device. For the mechanical wheelchairs, the testing would involve specific samples (e.g., a certain number of manufactured units) tested under laboratory conditions to the specified standards. The document does not specify the exact number of units tested, but rather confirms that "Design testing... met or passed the recognized test standard requirements."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for mechanical performance is defined by the objective pass/fail criteria of the engineering standards.
-
Adjudication method: Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. It is non-clinical performance testing of mechanical devices.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. These are mechanical devices, not algorithms.
-
The type of ground truth used: Not applicable in the AI/algorithmic sense. For mechanical testing, the "ground truth" is defined by the technical specifications and pass/fail criteria set forth in the international and national consensus standards (e.g., ISO, ANSI/RESNA).
-
The sample size for the training set: Not applicable. These are mechanical devices, not AI/ML models.
-
How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, and the full name is written in blue letters.
August 31, 2023
Ki Mobility LLC Mark Murphy Vice President of Operations 5201 Woodward Drive Stevens Point, Wisconsin 54481
Re: K223533
Trade/Device Name: Little Wave Arc; Little Wave Flip Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: LBE Dated: August 29, 2023 Received: August 30, 2023
Dear Mark Murphy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K223533
Device Name Little Wave Arc; Little Wave Flip
Indications for Use (Describe)
The Ki Mobility Little Wave Arc and Little Wave Flip manual wheelchairs are intended to provide mobility to pediatrics limited to a seating position.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) #: K223533 | 510(k) Summary | Prepared on: 2023-01-11 |
|---|---|---|
| ------------------- | ---------------- | ------------------------- |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | Ki Mobility LLC |
| Applicant Address | 5201 Woodward Drive Stevens Point WI 54481 United States |
| Applicant Contact Telephone | (715) 303-6447 |
| Applicant Contact | Mr. Mark Murphy |
| Applicant Contact Email | mmurphy@kimobility.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| Device Trade Name | Little Wave Arc; Little Wave Flip |
| Common Name | Mechanical wheelchair |
| Classification Name | Stroller, Adaptive |
| Regulation Number | 890.3850 |
| Product Code | LBE |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K151492 | R82 Kudu | LBE |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
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 reclines up to 60°, and elevating leg rest, all adjustable by an attendant.
Single pivot tilt systems provide the maximum horizontal and vertical translation of the occupant center of gravity. One of the goals of
Single pivot tilt systems provide the maximum horizontal and vertical translation of the occupant center of gravity. One of the goals of this device is to reduce the horizontal and vertical translation of the occupant center of gravity (CG) by utilizing a roller-link arm mechanism, where the roller is guided by a curved path to allow the rear of the seat frame to move forward while the front of the seat frame is guided upward by the link arm. This reduces the CG translation and thus allows for reduced titling force, reduced wheelbase for better maneuverability and increased comfort during tilting as compared to a single pivot tilt. An upper roller is guided laterally by a spine on the roller guide to provide lateral stability to the backrest tubes. Different styles of stabilizer/rigidizer/nars and handles can be utilized for added lateral backrest rigidity.
The Little Wave Arc side frames are constructed of high strength aluminum roller quides. There are 4 sizes of side frames for varying seat depth ranges. The chair folds using a set of aluminum X-brace style cross braces. There are 4 sizes of cross braces to accommodate varying seat width ranges. There are 4 sizes of aluminum seat tubes that match the 1 sizes of side frame. The backrest can be set to varying angles. The backrest folds down for stowage or transport. The reclining backrest is welded steel tubing, utilizing locking gas springs for recovery assistance as well as recline angle locking. An extended rear frame is utilized with the reclining backrest to move the rear wheels rearward by 4.5" for added stability.
The adjustable tubular aluminum seat and backrest frame 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 separate medical device adapted for use to the
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Little Wave Arc and is the primary contact surface to the occupant. Little Wave Arc components such as armrests and footrests will also have contact to the occupant.
The tilt angle is locked by using slide locking mechlocks) that utilize a torsion spring mounted in a fxed housing that binds around a telescoping shaft. These mechlocks are controlled by cables that are driven by a hand lever or a foot pedal. The hand actuated cables are either two levers that control two separate cables or a single cable that splits into two cables. The foot pedal controls two separate cables with a single pedal.
The chair may be used as a seat in a motor vehicle and conforms to ISO 7176-19 as well as ANS/RESNA WC-4 Section 19 requirements. The chair is intended to be pushed by an attendant or also may be self-propelled using larger wheels with handrims. The chair also offers a growing aluminum seat pan that allows up to 2" of growth in depth. The size ranges of seat pan match the size ranges of the seat tubes.
The Little Wave Arc XP, Little Wave Arc XPe and Little Wave Arc TTL order form variations of the same device to meet different market configuration requirements for pricing and reimbursement. All can be configured identically.
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 reclines up to 60°, and elevating leg rest, all adjustable by an attendant.
Single pivot tilt systems provide a simple system for repositioning the seat angle. One of this device is to provide tilting of the seat frame in a chair that folds horizontally, rather than laterally.
The Little Wave Flip base frame is constructed of high struded aluminum, steel and aluminum sheet aluminum. There are 3 sizes of aluminum seat tubes to accommodate varying seat depth ranges. The backrest folds down, the seat frame tilts anterior, and the axle bar swings under the base frame to provide horizontal folding action rather than lateral folding. Different strut lengths accommodate specific chair widths with no adjustment. A pivoting yoke attaches to the seat frame providing a single-pivot tilting paradigm. The high strength tubular aluminum seat frame utilizes telescoping members to allow adjustment of the seat frame. The Front frame and axle bar change angle relative to the side plates to provide height and wheelbase adjustment. The front frame also extends to provide additional height and wheelbase adjustment for varying seat depths.
The Little Wave Flip manual wheelchair has a folding backrest frame for transport. A non-folding backrest and a reclining backrest are options. The backrest can be set to varying andes. The optional reclining backrest is welded steel tubing, utilizing locking gas springs for recline angle recovery assistance as well as recline angle locking. An extended axle bar is utilized with the reclining backrest for added rearward stability.
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 mor use to the Little Wave Flip and is the primary contact to the occupant. Little Wave Flip components such as armests and footrests will also have contact to the occupant.
The tilt angle is locked by using slide locking mechlocks) that utilize a torsion spring mounted in a fxed housing that binds around a telescoping shaft. These mechlocks are controlled by cables that are driven by a hand lever or a foot pedal hand actuated levers are attached to the push handles to control two separate cables. The foot pedal, attached to the axle tube, controls two separate cables with a single pedal.
The chair may be used as a seat in a motor vehicle and conforms to ISO 7176-19 as well as ANS/RESNA WC-4 Section 19 requirements. The chair is intended to be pushed by an attendant or also may be self-propelled using larger wheels with handrims. The chair also offers a growing aluminum seat pan that allows up to 2" of growth in width and up to 3" in depth.
The Little Wave Flip XP, Little Wave Flip TTL order forms are order form variations of the same device to meet different market configuration requirements for pricing and reimbursement. All can be configured identically.
Intended Use/Indications for 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.
Indications for Use Comparison
The Ki Mobilty Little Wave Arc and Little Wave Flip manual wheelchairs are intended to provide mobility to persons limited to a sitting position. The primary use is by pediatrics in need of manual wheeled mobility offering an operator adjustable body support system. The Little Wave Arc and Little Wave Flip offer both seat tilt and an optional reclining backrest, with both adjustable by the attendant. This is consistent with the intended use of the R82 Kudu.
21 CFR 807 92(a)(5)
21 CFR 807.92(a)(5)
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| Ki Mobility Little Wave Arc | Ki Mobility Little Wave Flip | R82 Kudu | |||||
|---|---|---|---|---|---|---|---|
| Device | |||||||
| 510(k) Number | K223533 | K223533 | K151492 | ||||
| Intended Use | The Ki Mobility Little Wave Arc manualwheelchair is intended to provide mobility topersons limited to a sitting position. | The Ki Mobility Little Wave Flip manualwheelchair is intended to provide mobility topersons limited to a sitting position. | The device is a wheelchair for children andadults with disabilities. | ||||
| Indications for Use | The Ki Mobility Little Wave Arc manualwheelchair is intended to provide mobility topediatrics limited to a seating position. | The Ki Mobility Little Wave Flip manualwheelchair is intended to provide mobility topediatrics limited to a seating position. | The Kudu is a wheelchair intended for medicalpurposes to provide mobility to children limitedto a sitting position. It is designed for indoorand outdoor use over smooth surfaces. | ||||
| Design | Ki Mobility Little Wave Arc | Ki Mobility Little Wave Flip | R82 Kudu | ||||
| Weight Limit | 165lb/75kg (with or without transit) | 165lb/75kg (with or without transit) | 88lb/40kg - 162lb/60kg.Transit 88lb/40-kg - 125.5lb/57kg | ||||
| Frame Material | Aluminum | Aluminum, Steel | Aluminum | ||||
| Seat Width | 10" - 18" | 10" - 18" | 10" - 15" | ||||
| Seat Depth | 12" - 20" | 12" - 20" | 8.5" - 17.5" | ||||
| Seat Height | 14.5" - 19" | 13.5" - 20" | 14.5" - 18" | ||||
| Stowage Width | 14.4" (Folded Laterally) | 24.0" | 26.25" | ||||
| Stowage Depth | 31.7" | 28.9" | 34.5" | ||||
| Stowage Height | 20.1" | 27.6" | 24.5" | ||||
| Transit approved? | Yes (optional) | Yes (optional) | Yes (optional) | ||||
| Product weight | 44lb | 55lb | 42lb - 55lb, depending on size | ||||
| Turning Radius | 33.5" | 35" | 32.5" | ||||
| Tilt Range | 0° - 45° | 0° - 45° | -3° - 45° | ||||
| Standard | Standard | ||||||
| Frame Options | 1" OffsetExtended Frame for Vent and Battery Tray | 1" Offset Hanger | None | ||||
| Single hand tilt (left or right) | Single hand tilt | ||||||
| Tilt Action | Dual hand tiltFoot tilt (left or right) | Dual hand tiltFoot tilt | Dual hand tilt | ||||
| Back Angle Range | 85° - 115°, 5° increments, adjustable w/tools | 85° - 115°, 5° increments, adjustable w/tools | 85° - 120° adjustable without tools | ||||
| Height AdjustableFixed Height | Height AdjustableFixed Height | Fixed HeightHeight adjustable | |||||
| Backrest Styles | 60° Reclining backDynamic Rocker Back | 60° Reclining backDynamic Rocker Back | 30° Reclining back | ||||
| Adjustable Height: 18"-25" or 20"-27" | Height Adjustable: 18"-25" or 20"-27" | ||||||
| Back Heights | Fixed Height: 20", 22", 24", 26"Reclining Back: 22", 26" | Fixed Height: 20", 22", 24", 26"Reclining Back: 22", 26" | 14.5" - 24.5" | ||||
| Fixed push handle on back canes | Fixed Push handle on back canes | Fixed push handles on back canes | |||||
| Push Handles | Angle adjustable push handleRemovable Stroller handle | Angle adjustable push handleRemovable Stroller handle | Angle adjustable push handle | ||||
| Folding height adj. rigidizer bar | |||||||
| Rigidizer bars | Height adj. rigidizer bar (non-folding) | Height adj. rigidizer bar (non-folding) | Non-folding rigidizer handle | ||||
| Height Adj. T-Arm (Std, tall, low, pediatric)Tubular Flip Back Armrest | Height Adj. T-Arm (Std, tall, low, pediatric)Tubular Flip Back Armrest | Armrest w/tray holdersAngle Adjustable Armrest | |||||
| Armrests | Angle Adj. Locking Extendable Flip Back armrestDesk and Full Arm Pad – Standard and WaterfallstylesFoam Grip | Angle Adj. Locking Extendable Flip Back armrestDesk and Full Arm Pad – Standard and WaterfallstylesFoam Grip | |||||
| Push to lockPull to lockAttendant foot lockDrum brakeDual Drum brake w/push or pullHemi wheel lockWheel lock extension handles | Push to lockPull to lockAttendant foot lockDrum brakeDual Drum brake w/push or pullWheel lock extension handles | Push to lock (20, 22 and 24")Drum Brake (12.5") | |||||
| Wheel Lock | |||||||
| Anti-Tips | Removable/swing-up rear Anti-tips | Fold-up rear Anti-tips (not removable) | Swing away rear Anti-tips/tipping levers | ||||
| Mag: 12", 16" and 20" | Mag: 12", 16", 20", 22 and 24" | 12.5" mag | |||||
| Rear Wheels | Stainless Steel Spoke (18Ct.): 20" | Stainless Steel Spoke (18Ct.): 20", 22" and 24" | 20", 22" and 24" spoke wheels | ||||
| PneumaticPneumatic with Airless InsertSolid PolyurethaneAluminum AnodizedAluminum with Plastic Coating | PneumaticPneumatic with Airless InsertSolid PolyurethaneAluminum AnodizedAluminum with Plastic Coating | PneumaticSolid Polyurethane | |||||
| Tires | Handrims | Aluminum with Plastic Coating | Aluminum with Non-Slip Tape | Aluminum |
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| Projection Knob with Plastic Coating | Aluminum | ||
|---|---|---|---|
| Ergonomic Thumb Grip: Alum with Grip Coating | |||
| Camber | 0° | 0° | 6° (20, 22 and 24" only) |
| Caster Wheels(W x Ø) | 0.75" x 5" Lighted Roller Blade | 0.75" x 5" - Lighted Roller Blade | 6" Polyurethane |
| 1" x 5", 6", 7", 8" Polyurethane | 1" x 5", 6", 7", 8" - Polyurethane | 7" Polyurethane | |
| 1" x 5" Polyurethane Aluminum | 1" x 5" - Polyurethane Aluminum | 7" Pneumatic | |
| 1" x 6", 8" Pneumatic | 1" x 6", 8" - Pneumatic | ||
| 1.5" x 5", 6" Polyurethane | 1.5" x 5", 6" - Polyurethane | ||
| 1.5" x 5", 6" Soft Roll Aluminum | 1.5" x 5", 6" - Soft Roll Aluminum | ||
| 2" x 6" Polyurethane | 2" x 6" - Polyurethane | ||
| Caster Forks | Aluminum Fork | Aluminum Fork | Aluminum Fork |
| Swing Away Footrest, Extension mount | Swing Away Footrest, Extension mount | Individual removable footplates | |
| Swing Away Footrest, Front Mount | Swing Away Footrest, Front Mount | Center mount | |
| Footrests Hangers | Pro Elevating Leg rest (ext. and front mount) | Pro Elevating Leg rest (ext. and front mount) | |
| Contracture footrest (bilateral or center) | Contracture footrest (bilateral or center) | ||
| Residual limb support | Residual limb support | ||
| Hanger release (Classic, 4-way) | Hanger Release (Classic, 4-Way) | ||
| Composite | Composite | Composite Angle adjustable | |
| Composite Angle Adjustable | Composite Angle Adjustable | One piece center mounted | |
| Footplates | Aluminum Angle Adjustable | Aluminum Angle Adjustable | Formed footplates |
| Aluminum Locking Multi-angle adjustable | Aluminum Locking Multi-angle adjustable | ||
| One-piece Flip-Up Angle Adj. Footplate | One-piece Flip-Up Angle Adj. Footplate | ||
| Seating andpositioning | Width/depth adjustable seat pan | Width/depth adjustable seat pan | Depth adjustable seat pan |
| Seat Cushions | Seat Cushions | Seat cushions | |
| Backrest | Backrest | Backrest | |
| Lumbar pads | Lumbar pads | Headrest | |
| Shoulder guides | Shoulder guides | Harnesses/vests | |
| Headrest | Headrest | Laterals | |
| Supports (Chest and Truck) | Supports (Chest and Trunk) | Positioning belts | |
| Laterals | Laterals | Ankle straps | |
| Pelvic Positioning belts | Pelvic Positioning belts | Knee abductors | |
| Calf straps | Calf straps | Adductors | |
| Heel loops | Heel loops | Pommels | |
| Calf straps | |||
| Heel loops | |||
| Accessories | Ki Mobility Little Wave Arc | Ki Mobility Little Wave Flip | R82 Kudu |
| Vent/Battery tray | Ventilator Tray w/Battery box holder | No | Ventilator tray |
| Sideguards | Composite Side guards (adult and pediatric) | Composite Side guards (adult and pediatric) | Composite Side guards |
| Backpack/Pouch | Yes | Yes | Yes |
| Spoke Guards | Yes | Yes | Yes |
| ELR Gel Pads | Yes | Yes | No |
| IV Pole | Yes | Yes | No |
| 02 tank holder | Yes | No | Yes |
| Impact guards | Yes | Yes | No |
| Canopy | Yes | Yes | Yes |
| Tilt Stop | Yes | Yes | No |
| Tool Kit | Yes | Yes | Yes |
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Technological Comparison
21 CFR 807.92(a)(6)
The Ki Mobility Little Wave Arc manual wheelchair in comparison to predicate device shares intended use, similarity of configuration of components, wheels, and accessories.
The seat tilt function shares similar tilt andes, with the seat frame tilting relative to a stationary base frame supported by rear wheels and front caster wheels. The variation in the Little Wave Arc tilt design using a roller/linkage mechanism while still minimizing the translation of the occupant center of gravity. This contrasts the Kudu which uses a constant radius motion control rail moving through a set of rollers.
The Little Wave Arc aluminum base frame does not present a significant change to the safety or effectiveness of the wheelchair function and has been qualified through fatigue testing per the applicable standards.
The Little Wave Arc components and accessories do not pose new risks, being as safe and effective as the predicate device.
The Little Wave Arc is substantially equivalent to the predicate device in intended use, design, materials, and operating principles with no new issues of safety or effectiveness.
The Ki Mobilty Little Wave Flip manual wheelchair in comparison to predicate device shares intended use, similarity of configuration of components, wheels, and accessories.
The seat tilt function shares similar tilt angles, with the seat frame tilting relative to a stationary base frame supported by rear wheels and front caster wheels. The Little Wave Flip tilt design varies from the Kudu in that is uses slide locking mechanism for a simpler tilting mechanism. This contrasts the Kudu which uses a constant radius motion control rail moving through a set of rollers.
The Little Wave Flip aluminum base frame does not present a significant change to the safety or effectiveness of the wheelchair function and has been qualified through fatigue testing per the applicable standards.
The Little Wave Flip components and accessories do not pose new risks, being as safe and effective as the predicate device.
The Little Wave Flip is substantially equivalent to the predicate device in intended use, design, materials, and operating pinciples with no new issues of safety or effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The Little Wave Arc and Little Wave been tested to meet recognized consensus standards including:
ANSI/RESNA WC -4:2017 Section 19: Wheelchairs used as seats in motor vehicles
ISO-7176-1:2014 Determination of static stability
ISO 7176-5:2008 Determination of dimensions, mass, and maneuvering space
ISO 7176-7:1998 Measurement of seating and wheel dimensions
ISO 7176-8:2014 Requirements and test methods for static, impact, and fatigue strengths
ISO 7176-11:2012 Test Dummies
ISO 7176-13:1989 Determination of coefficient of friction of test surfaces
ISO 7176-15:1996 Requirements for information disclosure documentation and labeling
ISO 7176-16:2012 Resistance to ignition of postural support devices
ISO 7176-19:2022 Wheeled mobility devices for use as seats in motor vehicles
ISO 7176-22:2014 Set-up procedures
Design testing of Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements for manual wheelchairs, and which would apply to predicate devices.
Not Applicable
The Little Wave Arc and Little Wave Flip manual wheelchairs have intended use and similar technological characteristics as the predicate devices. The non-clinical testing to recognized standards exhibits that the device will perform as intended and risk analysis has documented risk reduction and identified requirements for labeling for safe and effective use of the device. The Little Wave Arc and Little Wave Flip are substantially equivalent to the predicate devices as shown in the product design comparison.
The conclusion from testing and comparison to predicate devices demonstrates that the Little Wave Flip are as safe, as effective, and performs as well as the legally marketed devices identified as predicate.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).