RGK Daily Range Wheelchairs
Device Facts
| Record ID | K200135 |
|---|---|
| Device Name | RGK Daily Range Wheelchairs |
| Applicant | Rgk Wheelchairs, Ltd. |
| Product Code | IOR · Physical Medicine |
| Decision Date | Sep 10, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3850 |
| Device Class | Class 1 |
Indications for 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, 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.
Device Story
RGK Daily Range Wheelchairs are manual, self-propelled, rigid-frame wheelchairs designed for mobility on stable, level surfaces. Constructed from aluminum or titanium, the device features four wheels, castors, sideguards, footplates, and wheel locks. Operated by the patient, the device is used in indoor and outdoor settings, including public, business, and private residences. The device provides seating for individuals unable to stand, facilitating independent movement. Healthcare providers use the device to support patient mobility and independence. Benefits include improved access to daily activities and environments for users with physical handicaps.
Clinical Evidence
No clinical data. Bench testing only. Testing included static stability (ISO 7176-1), brake effectiveness (ISO 7176-3), dimensions/maneuvering space (ISO 7176-5), seating/wheel measurements (ISO 7176-7), static impact/fatigue strength (ISO 7176-8), motor vehicle seat testing (ISO 7176-19, Tiga model only), and flammability (EN 1021-1/2).
Technological Characteristics
Mechanical, manually propelled wheelchair. Materials: 7000 grade aluminum (EN 573-3, EN 755-2/7, EN 754-2) and titanium (EN 10214). Components: wheels, castors, sideguards, footplates, wheel locks. Flame-resistant black nylon upholstery. Dimensions: made-to-measure, max 500mm x 700mm. User weight capacity: 125kg. No electronic or software components.
Indications for Use
Indicated for physically handicapped persons restricted to a sitting position and capable of manually causing the wheels to turn, including patients with spinal cord injury, paralysis, loss of extremity, and other diseases/conditions limiting mobility.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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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)<br>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 /<br>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:
1. EN573-3 Aluminum and Aluminum Alloys – Chemical Composition and Form of Wrought Products – Part
- 3: Chemical Composition and Form of Products
2. EN755-2 Aluminum and Aluminum Allows – Extruded Rod/Bar, Tube and Profiles – Part 2: Mechanical Properties
3. EN755-7 Aluminum and Aluminum Alloys – Extruded Rod/Bar, Tube, and Profiles. Seamless Tubes, Tolerances on Dimensions and Form
4. 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 Predicate<br>K021075 | Secondary Predicate<br>K123975 | Proposed:<br>K200135 | Description of<br>Similarities &<br>Differences |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Feature: | RGK Titanium family chairs<br>(Hi-Lite, Maxima, Ultima, and<br>Style) | Quickie Q7 Manual Wheelchair | RGK Aluminum family chairs<br>(Tiga, Tiga Sub4, Tiga FX, Octane<br>Sub4, Octane FX, and Hi-Lite) | |
| Intended Use: | | | | |
| 1.1 Intended Use: | The RGK Mechanical Daily Use<br>wheelchair range features self-<br>propelled rigid style wheelchairs<br>that provide seating for patients<br>who cannot stand on their own.<br>These chairs are intended for<br>patients with spinal cord injury,<br>Paralysis, loss of extremity and<br>other diseases and conditions<br>which limit a patient's mobility. | The Sunrise Medical Quickie® Q7<br>manual wheelchair is a self-<br>propelled rigid style wheelchair<br>that provides seating for patients<br>who cannot stand on their own.<br>This chair is intended for patients<br>with spinal cord injury, Paralysis,<br>loss of extremity and other<br>diseases and conditions which<br>limit a patient's mobility. | The RGK Daily Range Wheelchairs<br>features self-propelled rigid style<br>wheelchairs that provide seating<br>for patients who cannot stand on<br>their own. These chairs are<br>intended for patients with spinal<br>cord injury, Paralysis, loss of<br>extremity and other diseases and<br>conditions which limit a patient's<br>mobility. | Identical to Primary<br>Predicate. No Impact<br>on safety or<br>effectiveness. |
| 1.2 Indications for<br>Use: | The device is a mechanical<br>wheelchair with wheels that are<br>turned manually and allows<br>mobility to physically<br>handicapped persons restricted to<br>a sitting position and capable of<br>manually causing the wheels to<br>turn. | The Sunrise Medical Zippie and<br>Quickie Series Wheelchairs'<br>intended use is to provide<br>mobility to persons limited to a<br>sitting position. | The RGK Daily Range Wheelchairs<br>are mechanical wheelchairs with<br>wheels that are turned manually<br>and allows mobility to physically<br>handicapped persons restricted to<br>a sitting position and capable of<br>manually causing the wheels to<br>turn. | Identical to Primary<br>Predicate. No Impact<br>on safety or<br>effectiveness. |
| 1.3 Target<br>Population: | Patients with spinal cord injury,<br>paralysis, loss of extremity and<br>other diseases and conditions<br>which limit a patient's mobility. | Patients with spinal cord injury,<br>paralysis, loss of extremity and<br>other diseases and conditions<br>which limit a patient's mobility. | Patients with spinal cord injury,<br>paralysis, loss of extremity and<br>other diseases and conditions<br>which limit a patient's mobility. | Identical to Primary<br>Predicate. No Impact<br>on safety or<br>effectiveness. |
| 1.4 Where Used: | Indoors and outdoors. Public,<br>business and private residences. | Indoors and outdoors. Public,<br>business and private residences. | Indoors and outdoors. Public,<br>business and private residences. | Identical to Primary<br>Predicate. No Impact<br>on safety or<br>effectiveness. |
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| Feature: | Primary Predicate<br>K021075<br>RGK Titanium family chairs<br>(Hi-Lite, Maxima, Ultima, and Style) | Secondary Predicate<br>K123975<br>Quickie Q7 Manual Wheelchair | Proposed:<br>K200135<br>RGK Aluminum family chairs<br>(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 Predicate<br>K021075<br>RGK Titanium family chairs<br>(Hi-Lite, Maxima, Ultima, and<br>Style) | Secondary Predicate<br>K123975<br>Quickie Q7 Manual Wheelchair | Proposed:<br>K200135<br>RGK Aluminum family chairs<br>(Tiga, Tiga Sub4, Tiga FX, Octane<br>Sub4, Octane FX, and Hi-Lite) | Description of<br>Similarities &<br>Differences |
| 3.3 Drive wheels | Fusion 16 spoke<br>24" Spinergy SPOX<br>25" Spinergy SPOX<br>26" Spinergy SPOX<br>24" Spinergy LX<br>25" Spinergy LX<br>26" Spinergy LX<br>24" Spinergy BLX<br>25" Spinergy BLX<br>26" Spinergy BLX<br>24" Spinergy CLX<br>25" Spinergy CLX<br>26" Spinergy CLX<br>24" Spinergy XLX<br>25" Spinergy XLX<br>26" Spinergy XLX | 20" Mag Wheel 5-Spoke<br>22" Mag Wheel 5-Spoke<br>24" Mag Wheel 5-Spoke<br>20" Lite Spoke Wheel<br>22" Lite Spoke Wheel<br>24" Lite Spoke Wheel<br>25" Lite Spoke Wheel<br>26" Lite Spoke Wheel<br>22" Ultra Lightweight Spoke<br>Wheel<br>24" Ultra Lightweight Spoke<br>Wheel<br>25" Ultra Lightweight Spoke<br>Wheel<br>22" Spinergy SPOX Black<br>24" Spinergy SPOX Black<br>25" Spinergy SPOX Black<br>26" Spinergy SPOX Black<br>22" Spinergy LX Black<br>24" Spinergy LX Black<br>25" Spinergy LX Black<br>26" Spinergy LX Black<br>24" Mountain | Fusion 16 spoke<br>24" Spinergy SPOX<br>25" Spinergy SPOX<br>26" Spinergy SPOX<br>24" Spinergy LX<br>25" Spinergy LX<br>26" Spinergy LX<br>24" Spinergy BLX<br>25" Spinergy BLX<br>26" Spinergy BLX<br>24" Spinergy CLX<br>25" Spinergy CLX<br>26" Spinergy CLX<br>24" Spinergy XLX<br>25" Spinergy XLX<br>26" Spinergy XLX | Identical to Primary<br>Predicate. No Impact<br>on safety or<br>effectiveness. |
| Feature: | Primary Predicate<br>K021075 | Secondary Predicate<br>K123975 | Proposed:<br>K200135 | Description of<br>Similarities &<br>Differences |
| 3.4 Castor Wheels | RGK Titanium family chairs<br>(Hi-Lite, Maxima, Ultima, and<br>Style) | Quickie Q7 Manual Wheelchair | RGK Aluminum family chairs<br>(Tiga, Tiga Sub4, Tiga FX, Octane<br>Sub4, Octane FX, and Hi-Lite) | |
| | 3" Froglegs Aluminium | 3" Micro | 3" Froglegs Aluminium | Identical to Predicate.<br>No Impact on safety or<br>effectiveness. |
| | 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 Handrim<br>Options | Aluminium Hard Anodised<br>Surge LT<br>Tetra Grip<br>Para Grip<br>Titanium<br>Stainless steel<br>Ergo Grip | Aluminum Anodized<br>Plastic Coated<br>Natural Fit - Standard Grip<br>Natural Fit - Super Grip<br>Natural Fit - No Thumb Grip<br>Natural Fit LT - Standard Grip<br>Natural Fit LT - Super Grip<br>Natural Fit LT - No Thumb Grip<br>The Surge - Oval w/Gription Strip<br>The Surge LT - Oval w/ Gription<br>Strip<br>Q-Grip Neoprene Coated<br>Spinorgy Flox Rim | Aluminium Hard Anodised<br>Surge LT<br>Tetra Grip<br>Para Grip<br>Titanium<br>Stainless steel<br>Ergo Grip | Identical to Primary<br>Predicate. No Impact<br>on safety or<br>effectiveness. |
| Feature: | Primary Predicate<br>K021075 | Secondary Predicate<br>K123975 | Proposed:<br>K200135 | Description of<br>Similarities &<br>Differences |
| 3.6 Cosmetic | RGK Titanium family chairs<br>(Hi-Lite, Maxima, Ultima, and<br>Style)<br>Product is made from a titanium<br>frame with a selection of powder<br>coated colour finished as well as a<br>satin raw finish. | Quickie Q7 Manual Wheelchair<br>Product is made from an<br>aluminum frame with a selection<br>of powder coated color finishes as<br>well as some anodized options. | RGK Aluminum family chairs<br>(Tiga, Tiga Sub4, Tiga FX, Octane<br>Sub4, Octane FX, and Hi-Lite)<br>Product is made from an<br>aluminium frame or titanium<br>frame with a selection of powder<br>coated colour finishes as well as<br>polished and brushed options. | Identical to Primary<br>and Secondary<br>Predicates. No impact<br>on safety or<br>effectiveness. |
| 3.7 Picture | | | | Substantially<br>equivalent to Primary<br>and Secondary<br>Predicates. No impact<br>on safety or<br>effectiveness. |
| 4. Seat: | | | | |
| 4.1 Seat Options | seatplate or seat sling with<br>cushion | seatplate or seat sling with<br>cushion | seatplate or seat sling with<br>cushion | Identical to Primary<br>and Secondary<br>Predicates. No impact<br>on safety or<br>effectiveness. |
| 4.2 Minimum Seat<br>Height | 360mm | 330mm rear<br>400mm front | 360mm | Identical to Primary<br>Predicate. No impact<br>on safety or<br>effectiveness. |
| 4.3 Camber angle | $1^\circ$<br>$2^\circ$<br>$3^\circ$ | $0^\circ$<br>$3^\circ$<br>$6^\circ$ | $0^\circ$<br>$1^\circ$<br>$2^\circ$<br>$3^\circ$<br>$5^\circ$ | Substantially<br>equivalent to Primary<br>and Secondary<br>predicates. No impact<br>on safety or<br>effectiveness. |
| Feature: | Primary Predicate<br>K021075 | Secondary Predicate<br>K123975 | Proposed:<br>K200135 | Description of<br>Similarities &<br>Differences |
| | RGK Titanium family chairs<br>(Hi-Lite, Maxima, Ultima, and<br>Style) | Quickie Q7 Manual Wheelchair | RGK Aluminum family chairs<br>(Tiga, Tiga Sub4, Tiga FX, Octane<br>Sub4, Octane FX, and Hi-Lite) | |
| COG Adjustment | 25-125mm | 0-100mm | 25-125mm | Identical to Primary<br>Predicate. No impact<br>on safety or<br>effectiveness. |
| Seat Dimensions | Width 250-440mm | Width 300-500mm | Width 300-500mm | Identical to Secondary<br>Predicate. No Impact<br>on safety or<br>effectiveness. |
| | Depth 250-440mm | Depth 300-500mm | Depth 300-500mm…
