(233 days)
The RGK Daily Range Wheelchairs are mechanical wheels that are turned manually and allows mobility to physically handicapped persons restricted to a sitting position and capable of manually causing the wheels to turn.
The RGK Daily Range Wheelchairs are mechanical wheelchairs that include four wheels, an aluminum or titanium frame, and a black nylon upholstery that is flame resistant. Each wheelchair includes multiple components such as wheels, castors, sideguards, footplates and wheel locks.
The provided text describes the 510(k) premarket notification for RGK Daily Range Wheelchairs. As this is a submission for a mechanical wheelchair, it does not involve AI/ML technology or clinical studies for diagnostic accuracy. Therefore, many of the requested categories in your prompt are not applicable to this document.
However, I can extract the information relevant to the acceptance criteria and non-clinical testing performed to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "No FDA performance standards have been established for mechanical wheelchairs." However, the device was tested against international ISO and EN standards. The acceptance criteria would be successful completion of these tests.
| Test Parameter / Standard | Acceptance Criteria (Implied: Pass Standard) | Reported Device Performance |
|---|---|---|
| Static Stability (ISO 7176-1) | Device stable under specified conditions | Not explicitly stated but implied successful completion to conclude substantial equivalence. |
| Effectiveness of Brakes (ISO 7176-3) | Brakes perform as required by standard | Not explicitly stated but implied successful completion to conclude substantial equivalence. |
| Dimension, Mass, and Maneuvering Space (ISO 7176-5) | Conforms to specified dimensions, mass, and maneuvering space requirements | Not explicitly stated but implied successful completion to conclude substantial equivalence. |
| Measurement of Seating and Wheel Measurements (ISO 7176-7) | Seating and wheel measurements conform to standard | Not explicitly stated but implied successful completion to conclude substantial equivalence. |
| Requirements and Test Methods for Static Impact and Fatigue Strength (ISO 7176-8) | Withstands static impact and fatigue as per standard | Not explicitly stated but implied successful completion to conclude substantial equivalence. |
| Wheeled mobility devices for use as seats in motor vehicles (ISO 7176-19) | Tiga model only meets requirements for use in motor vehicles | Not explicitly stated but implied successful completion to conclude substantial equivalence (for Tiga model). |
| Flammability (EN 1021-1 and EN 1021-2) | Upholstery meets flammability requirements | Not explicitly stated but implied successful completion to conclude substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size for each test for the RGK Daily Range Wheelchairs. These are likely mechanical tests performed on a limited number of physical units, not a "data set" in the context of AI/ML. The tests are for the device itself. The provenance of these tests is not explicitly stated but assumed to be from the manufacturer (RGK Wheelchairs, Ltd. in the United Kingdom). The tests are prospective in the sense that they are performed on the device before market authorization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are non-clinical engineering and material tests, not diagnostic assessments requiring clinician experts to establish ground truth. The "ground truth" is determined by the physical properties and performance of the wheelchair against defined standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no adjudication method described as it's not a clinical or AI performance study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a mechanical wheelchair, not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical wheelchair, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these tests are the objective pass/fail criteria defined by the respective ISO and EN standards for mechanical wheelchairs. For example, a stability test has a specific physical outcome (falls or does not fall) when subjected to defined forces.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or "ground truth for a training set." The design and manufacturing process for the wheelchair (including material testing) are described, but this is distinct from training an algorithm. The material specifications (like EN573-3, EN755-2, EN755-7, EN754-2, EN 10204) could be seen as baseline "truth" for material quality.
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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 logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
September 9, 2020
RGK Wheelchairs, Ltd. Devin McElroy Senior Director OA/RA at Sunrise Medical (US) LLC Units 8 B/C Ring RD 2 Burntwood Business Park Burntwood, Staffordshire, United Kingdom, WS7 3JQ
Re: K200135
Trade/Device Name: RGK Daily Range Wheelchairs Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: June 18, 2020 Received: June 19, 2020
Dear Devin McElroy:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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 medical devices and radiation-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,
Heather Dean, PhD Acting 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) K200135
Device Name RGK Daily Range Wheelchairs
Indications for Use (Describe)
The RGK Daily Range Wheelchairs are mechanical wheels that are turned manually and allows mobility to physically handicapped persons restricted to a sitting position and capable of manually causing the wheels to turn.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
MANUFACTURER AND 510(k) OWNER
RGK Wheelchairs, Ltd. Units 8 B/C Ring Rd 2, Burntwood Business Park, Burntwood, Staffordshire, United Kingdom, WS7 3JQ Telephone: +44-1543-670077
OFFICIAL CONTACT / U.S. AGENT
Devin I. McElroy, MBA/TM, Sr. Director QA/RA, North America Sunrise Medical (US) LLC 5842 N Business Park Ave., Fresno, CA 93727 Telephone: +1 (559) 294-2374 devin.mcelroy@sunmed.com Email: Website: www.sunmed.com
REPRESENTATIVE / CONSULTANT
Michelle Rubin-Onur, Ph.D. Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547
| Email: | mrubin@acknowledge-rs.com, akomiyama@acknowledge-rs.com |
|---|---|
| Website: | www.AcKnowledge-RS.com |
DEVICE INFORMATION
| Proprietary Name/Trade Name: | RGK Daily Range Wheelchairs |
|---|---|
| Common Name: | Mechanical wheelchair |
| Regulation Number: | 21 CFR 890.3850 |
| Class: | I |
| Product Code: | IOR |
| Premarket Review: | Physical Medicine |
| Review Panel: | Neurological and Physical Medicine Devices (OHT5)Neuromodulation and Physical Medicine Devices (DHT5B) |
PREDICATE DEVICE IDENTIFICATION
The RGK Daily Range Wheelchairs are substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K021075 | Mechanical Daily Use Wheelchair /First World Services, Inc. | ✓ |
| K123975 | Quickie and Zippie Series / Sunrise Medical |
DEVICE DESCRIPTIVE INFORMATION
INTENDED USE
The RGK Daily Range Wheelchairs are intended to be manually propelled on level stable surfaces without loose materials such as gravel and stones. Typical urban road and pavement surfaces such as concrete,
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asphalt, and tarmac are examples of outdoor intended use surfaces. The subject device can also be used on all traditional interior surfaces such as carpet, laminate and tile flooring. The RGK Daily Range Wheelchairs should not be used on unstable, inconsistent, or loose surfaces such as grass, loose stone, or cobblestone.
INDICATIONS FOR USE (FROM FORM FORM FDA 3881)
The RGK Daily Range Wheelchairs are mechanical wheels that are turned manually and allows mobility to physically handicapped persons restricted to a sitting position and capable of manually causing the wheels to turn.
DEVICE DESCRIPTION
The RGK Daily Range Wheelchairs are mechanical wheelchairs that include four wheels, an aluminum or titanium frame, and a black nylon upholstery that is flame resistant. Each wheelchair includes multiple components such as wheels, castors, sideguards, footplates and wheel locks.
The RGK Daily Range Wheelchairs include both aluminum and titanium frames are made from aluminum pipes provided by Thyssenkrugg Materials (UK) Ltd and inspected by Alumag Aluminum Corporation. The inspection reports from Alumag Aluminum Corporation, include chemical composition and tensile strength testing per:
- EN573-3 Aluminum and Aluminum Alloys – Chemical Composition and Form of Wrought Products – Part
- 3: Chemical Composition and Form of Products
-
EN755-2 Aluminum and Aluminum Allows – Extruded Rod/Bar, Tube and Profiles – Part 2: Mechanical Properties
-
EN755-7 Aluminum and Aluminum Alloys – Extruded Rod/Bar, Tube, and Profiles. Seamless Tubes, Tolerances on Dimensions and Form
-
EN754-2 Aluminum and Aluminum Alloys- Cold Drawl Rod/Bar and Tube – Part 2: Mechanical Properties
Titanium frames are made from titanium pipes provided by Shenyang Dongli Titanium Company, Ltd. Dimensional measurements, chemical composition, and mechanical strength of each pipe are assessed to ensure compliance to EN 10204 Metallic Products: Types of Inspection Document.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
RGK Wheelchairs, Ltd believes that the subject device is substantially equivalent to the predicate devices. There are no differences in: control mechanisms, operating principles, or energy types; sterilization, cleaning, or disinfection; intended use or effective lifetime; or dimensions, performance specifications, components, accessories, or patient/user interfaces between the RGK Daily Range Wheelchairs and the predicate devices. Design differences have no new considerations that impact safety, effectiveness, or indications for use.
The subject device has a similar design and dimensions and uses similar or identical materials as the device(s) cleared in K021075 (Primary Predicate) and K123975 (Secondary Predicate). The subject device has the same intended use and similar technological characteristics to the devices cleared in K021075 and K123975. The device has similar instrumentation to the device cleared in K021075 and K123975. The RGK Daily Range Wheelchairs have undergone testing to ensure that any differences in technological characteristics do not affect safety and effectiveness when compared to the predicate devices.
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| Primary PredicateK021075 | Secondary PredicateK123975 | Proposed:K200135 | Description ofSimilarities &Differences | |
|---|---|---|---|---|
| Feature: | RGK Titanium family chairs(Hi-Lite, Maxima, Ultima, andStyle) | Quickie Q7 Manual Wheelchair | RGK Aluminum family chairs(Tiga, Tiga Sub4, Tiga FX, OctaneSub4, Octane FX, and Hi-Lite) | |
| Intended Use: | ||||
| 1.1 Intended Use: | The RGK Mechanical Daily Usewheelchair range features self-propelled rigid style wheelchairsthat provide seating for patientswho cannot stand on their own.These chairs are intended forpatients with spinal cord injury,Paralysis, loss of extremity andother diseases and conditionswhich limit a patient's mobility. | The Sunrise Medical Quickie® Q7manual wheelchair is a self-propelled rigid style wheelchairthat provides seating for patientswho cannot stand on their own.This chair is intended for patientswith spinal cord injury, Paralysis,loss of extremity and otherdiseases and conditions whichlimit a patient's mobility. | The RGK Daily Range Wheelchairsfeatures self-propelled rigid stylewheelchairs that provide seatingfor patients who cannot stand ontheir own. These chairs areintended for patients with spinalcord injury, Paralysis, loss ofextremity and other diseases andconditions which limit a patient'smobility. | Identical to PrimaryPredicate. No Impacton safety oreffectiveness. |
| 1.2 Indications forUse: | The device is a mechanicalwheelchair with wheels that areturned manually and allowsmobility to physicallyhandicapped persons restricted toa sitting position and capable ofmanually causing the wheels toturn. | The Sunrise Medical Zippie andQuickie Series Wheelchairs'intended use is to providemobility to persons limited to asitting position. | The RGK Daily Range Wheelchairsare mechanical wheelchairs withwheels that are turned manuallyand allows mobility to physicallyhandicapped persons restricted toa sitting position and capable ofmanually causing the wheels toturn. | Identical to PrimaryPredicate. No Impacton safety oreffectiveness. |
| 1.3 TargetPopulation: | Patients with spinal cord injury,paralysis, loss of extremity andother diseases and conditionswhich limit a patient's mobility. | Patients with spinal cord injury,paralysis, loss of extremity andother diseases and conditionswhich limit a patient's mobility. | Patients with spinal cord injury,paralysis, loss of extremity andother diseases and conditionswhich limit a patient's mobility. | Identical to PrimaryPredicate. No Impacton safety oreffectiveness. |
| 1.4 Where Used: | Indoors and outdoors. Public,business and private residences. | Indoors and outdoors. Public,business and private residences. | Indoors and outdoors. Public,business and private residences. | Identical to PrimaryPredicate. No Impacton safety oreffectiveness. |
| 11-40>risc18SCC |
|---|
| 1cat2œ1 |
| 1t5e |
| 1115. |
| ebl6 |
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| Feature: | Primary PredicateK021075RGK Titanium family chairs(Hi-Lite, Maxima, Ultima, and Style) | Secondary PredicateK123975Quickie Q7 Manual Wheelchair | Proposed:K200135RGK Aluminum family chairs(Tiga, Tiga Sub4, Tiga FX, Octane Sub4, Octane FX, and Hi-Lite) | Description of Similarities & Differences |
|---|---|---|---|---|
| 2. General: | ||||
| 2.1 User Weight (Max): | 125kg | 120kg | 125kg | Identical to Primary Predicate. No Impact on safety or effectiveness. |
| 2.2 Structural Materials: | Titanium frame with standard foams and covers for the seat. | 7000 grade aluminum frame with standard foams and covers for the seat. | 7000 grade aluminium and titanium frames with standard foams and covers for the seat. | Identical to Primary and Secondary Predicates. No Impact on safety or effectiveness. |
| 2.3 Biocompatibility: | Uses materials common to many wheelchairs. | Uses materials common to many wheelchairs. | Uses materials common to many wheelchairs. | Identical to Primary and Secondary Predicates. No Impact on safety or effectiveness. |
| 2.4 Maximum Speed: | Manually propelled/ user controlled speed | Manually propelled/ user controlled speed | Manually propelled/ user controlled speed | Identical to Primary and Secondary Predicates. No Impact on safety or effectiveness. |
| B. Base: | ||||
| 3.1 Overall dimensions (width by height) | Made to measure frame, typical Max 500mm x 700mm | 500mm x 790mm | Made to measure frame, typical Max 500mm x 700mm | Identical to Primary Predicate. No Impact on safety or effectiveness. |
| 3.2 Maximum total weight (without wheels) | 9kg | 9kg | 9kg | Identical to Primary and Secondary Predicates (when using equivalent configurations). No Impact on safety or effectiveness. |
| Feature: | Primary PredicateK021075RGK Titanium family chairs(Hi-Lite, Maxima, Ultima, andStyle) | Secondary PredicateK123975Quickie Q7 Manual Wheelchair | Proposed:K200135RGK Aluminum family chairs(Tiga, Tiga Sub4, Tiga FX, OctaneSub4, Octane FX, and Hi-Lite) | Description ofSimilarities &Differences |
| 3.3 Drive wheels | Fusion 16 spoke24" Spinergy SPOX25" Spinergy SPOX26" Spinergy SPOX24" Spinergy LX25" Spinergy LX26" Spinergy LX24" Spinergy BLX25" Spinergy BLX26" Spinergy BLX24" Spinergy CLX25" Spinergy CLX26" Spinergy CLX24" Spinergy XLX25" Spinergy XLX26" Spinergy XLX | 20" Mag Wheel 5-Spoke22" Mag Wheel 5-Spoke24" Mag Wheel 5-Spoke20" Lite Spoke Wheel22" Lite Spoke Wheel24" Lite Spoke Wheel25" Lite Spoke Wheel26" Lite Spoke Wheel22" Ultra Lightweight SpokeWheel24" Ultra Lightweight SpokeWheel25" Ultra Lightweight SpokeWheel22" Spinergy SPOX Black24" Spinergy SPOX Black25" Spinergy SPOX Black26" Spinergy SPOX Black22" Spinergy LX Black24" Spinergy LX Black25" Spinergy LX Black26" Spinergy LX Black24" Mountain | Fusion 16 spoke24" Spinergy SPOX25" Spinergy SPOX26" Spinergy SPOX24" Spinergy LX25" Spinergy LX26" Spinergy LX24" Spinergy BLX25" Spinergy BLX26" Spinergy BLX24" Spinergy CLX25" Spinergy CLX26" Spinergy CLX24" Spinergy XLX25" Spinergy XLX26" Spinergy XLX | Identical to PrimaryPredicate. No Impacton safety oreffectiveness. |
| Feature: | Primary PredicateK021075 | Secondary PredicateK123975 | Proposed:K200135 | Description ofSimilarities &Differences |
| 3.4 Castor Wheels | RGK Titanium family chairs(Hi-Lite, Maxima, Ultima, andStyle) | Quickie Q7 Manual Wheelchair | RGK Aluminum family chairs(Tiga, Tiga Sub4, Tiga FX, OctaneSub4, Octane FX, and Hi-Lite) | |
| 3" Froglegs Aluminium | 3" Micro | 3" Froglegs Aluminium | Identical to Predicate.No Impact on safety oreffectiveness. | |
| 4" Softroll | 4" Low Profile Polyurethane | 4" Softroll | ||
| 4" Froglegs Carbon Centre | 4" Micro Lighted | 4" Froglegs Carbon Centre | ||
| 4" Froglegs Aluminium Centre | 4" x 1" Aluminum Polyurethane | 4" Froglegs Aluminium Centre | ||
| 5" Softroll | 4" x 1.25" Semi Pneumatic | 5" Softroll | ||
| 5" Pneumatic Aluminium Centre | 4" x 1.5" Aluminum Soft Roll | 5" Pneumatic Aluminium Centre | ||
| 5" Froglegs Aluminium Centre | 5" Low Profile Polyurethane | 5" Froglegs Aluminium Centre | ||
| 6" Softroll | 5" Micro lighted | 6" Softroll | ||
| 5" x 1" Aluminum Polyurethane | 6" Froglegs Aluminium Centre | |||
| 5" x 1.5" Semi-Pneumatic | ||||
| 5" Soft Roll (Grey) | ||||
| 5" x 1.5" Aluminum Soft Roll | ||||
| 6" Polyurethane | ||||
| 6" Pneumatic | ||||
| 6" x 1.5" Semi Pneumatic | ||||
| 6" x 1.5" Aluminum Soft Roll | ||||
| 3.5 HandrimOptions | Aluminium Hard AnodisedSurge LTTetra GripPara GripTitaniumStainless steelErgo Grip | Aluminum AnodizedPlastic CoatedNatural Fit - Standard GripNatural Fit - Super GripNatural Fit - No Thumb GripNatural Fit LT - Standard GripNatural Fit LT - Super GripNatural Fit LT - No Thumb GripThe Surge - Oval w/Gription StripThe Surge LT - Oval w/ GriptionStripQ-Grip Neoprene CoatedSpinorgy Flox Rim | Aluminium Hard AnodisedSurge LTTetra GripPara GripTitaniumStainless steelErgo Grip | Identical to PrimaryPredicate. No Impacton safety oreffectiveness. |
| Feature: | Primary PredicateK021075 | Secondary PredicateK123975 | Proposed:K200135 | Description ofSimilarities &Differences |
| 3.6 Cosmetic | RGK Titanium family chairs(Hi-Lite, Maxima, Ultima, andStyle)Product is made from a titaniumframe with a selection of powdercoated colour finished as well as asatin raw finish. | Quickie Q7 Manual WheelchairProduct is made from analuminum frame with a selectionof powder coated color finishes aswell as some anodized options. | RGK Aluminum family chairs(Tiga, Tiga Sub4, Tiga FX, OctaneSub4, Octane FX, and Hi-Lite)Product is made from analuminium frame or titaniumframe with a selection of powdercoated colour finishes as well aspolished and brushed options. | Identical to Primaryand SecondaryPredicates. No impacton safety oreffectiveness. |
| 3.7 Picture | Substantiallyequivalent to Primaryand SecondaryPredicates. No impacton safety oreffectiveness. | |||
| 4. Seat: | ||||
| 4.1 Seat Options | seatplate or seat sling withcushion | seatplate or seat sling withcushion | seatplate or seat sling withcushion | Identical to Primaryand SecondaryPredicates. No impacton safety oreffectiveness. |
| 4.2 Minimum SeatHeight | 360mm | 330mm rear400mm front | 360mm | Identical to PrimaryPredicate. No impacton safety oreffectiveness. |
| 4.3 Camber angle | $1^\circ$$2^\circ$$3^\circ$ | $0^\circ$$3^\circ$$6^\circ$ | $0^\circ$$1^\circ$$2^\circ$$3^\circ$$5^\circ$ | Substantiallyequivalent to Primaryand Secondarypredicates. No impacton safety oreffectiveness. |
| Feature: | Primary PredicateK021075 | Secondary PredicateK123975 | Proposed:K200135 | Description ofSimilarities &Differences |
| RGK Titanium family chairs(Hi-Lite, Maxima, Ultima, andStyle) | Quickie Q7 Manual Wheelchair | RGK Aluminum family chairs(Tiga, Tiga Sub4, Tiga FX, OctaneSub4, Octane FX, and Hi-Lite) | ||
| COG Adjustment | 25-125mm | 0-100mm | 25-125mm | Identical to PrimaryPredicate. No impacton safety oreffectiveness. |
| Seat Dimensions | Width 250-440mm | Width 300-500mm | Width 300-500mm | Identical to SecondaryPredicate. No Impacton safety oreffectiveness. |
| Depth 250-440mm | Depth 300-500mm | Depth 300-500mm | ||
| Series | Underseat ScissorCompact ScissorOut Front Compact ScissorPush to LockOut Front Push to LockOmit Wheel Locks | Direct MountHigh Mount PushHigh Mount PullErgo ScissorCompact6" Extension Handle Pair | Underseat ScissorCompact ScissorOut Front Compact ScissorPush to LockOut Front Push to LockOmit Wheel Locks | Identical to PrimaryPredicate. No Impacton safety oreffectiveness. |
| Brakes | ||||
| Sideguards | PlasticAluminiumAluminium WeldedAluminium LiftoutAluminium with FenderCarbon FibreCarbon Fibre with Fender | Plastic - StandardPlastic - LowAluminumAluminum with FenderCarbon FiberCarbon Fiber with Fender | PlasticAluminiumAluminium WeldedAluminium LiftoutAluminium with FenderCarbon FibreCarbon Fibre with Fender | Identical to PrimaryPredicate. No Impacton safety oreffectiveness. |
| Backrest | Fixed HeightAdjustable HeightFolding BackrestErgo Backrest | Non-FoldingFolding Lock-Down AngleAdjustableFreestyle Backrest System Non-FoldingFreestyle Backrest System Folding | Fixed HeightAdjustable HeightFolding BackrestErgo Backrest | Identical to PrimaryPredicate. No Impacton safety oreffectiveness. |
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SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for mechanical wheelchairs. Clinical testing is not applicable to mechanical wheelchairs; therefore, clinical testing was not performed.
The following tests were performed to demonstrate equivalence to the predicate devices:
- . Determination of static stability (per ISO 7176-1)
- Effectiveness of Brakes (per ISO 7176-3) ●
- . Dimension, Mass, and Maneuvering Space (per ISO 7176-5)
- . Measurement of Seating and Wheel Measurements (per ISO 7176-7)
- Requirements and Test Methods for Static Impact and Fatigue Strength (per ISO 7176-8)
- . Wheeled mobility devices for use as seats in motor vehicles (per ISO 7176-19) – Tiga model only
- Flammability (per EN 1021-1 and EN 1021-2)
CONCLUSION
Based on the information performed, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices.
§ 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).