(233 days)
Not Found
No
The device description and performance studies indicate a purely mechanical device with no mention of AI or ML components.
No.
The device description indicates it is a mechanical wheelchair designed for mobility, not to treat or diagnose a medical condition.
No
The device description indicates that the RGK Daily Range Wheelchairs are mechanical mobility aids for physically handicapped persons, designed for transportation and movement, not for diagnosing medical conditions.
No
The device is a mechanical wheelchair with physical components like wheels, frame, and upholstery, and the performance studies focus on mechanical testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description: The RGK Daily Range Wheelchairs are described as mechanical devices for mobility, designed to assist physically handicapped persons. They are used externally and do not involve testing bodily samples.
- Intended Use: The intended use is for mobility and allowing physically handicapped persons to move. This is a functional, external use, not a diagnostic one.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes.
Therefore, based on the provided information, the RGK Daily Range Wheelchairs are not IVD devices. They are mobility aids.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IOR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
No FDA performance standards have been established for mechanical wheelchairs. Clinical testing is not applicable to mechanical wheelchairs; therefore, clinical testing was not performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
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,
4
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.
5
| | Primary Predicate
K021075 | Secondary Predicate
K123975 | Proposed:
K200135 | Description of
Similarities &
Differences |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Feature: | RGK Titanium family chairs
(Hi-Lite, Maxima, Ultima, and
Style) | Quickie Q7 Manual Wheelchair | RGK Aluminum family chairs
(Tiga, Tiga Sub4, Tiga FX, Octane
Sub4, Octane FX, and Hi-Lite) | |
| Intended Use: | | | | |
| 1.1 Intended Use: | The RGK Mechanical Daily Use
wheelchair range features self-
propelled rigid style wheelchairs
that provide seating for patients
who cannot stand on their own.
These chairs are intended for
patients with spinal cord injury,
Paralysis, loss of extremity and
other diseases and conditions
which limit a patient's mobility. | The Sunrise Medical Quickie® Q7
manual wheelchair is a self-
propelled rigid style wheelchair
that provides seating for patients
who cannot stand on their own.
This chair is intended for patients
with spinal cord injury, Paralysis,
loss of extremity and other
diseases and conditions which
limit a patient's mobility. | The RGK Daily Range Wheelchairs
features self-propelled rigid style
wheelchairs that provide seating
for patients who cannot stand on
their own. These chairs are
intended for patients with spinal
cord injury, Paralysis, loss of
extremity and other diseases and
conditions which limit a patient's
mobility. | Identical to Primary
Predicate. No Impact
on safety or
effectiveness. |
| 1.2 Indications for
Use: | The device is a mechanical
wheelchair with 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 Sunrise Medical Zippie and
Quickie Series Wheelchairs'
intended use is to provide
mobility to persons limited to a
sitting position. | The RGK Daily Range Wheelchairs
are mechanical wheelchairs with
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. | Identical to Primary
Predicate. No Impact
on safety or
effectiveness. |
| 1.3 Target
Population: | Patients with spinal cord injury,
paralysis, loss of extremity and
other diseases and conditions
which limit a patient's mobility. | Patients with spinal cord injury,
paralysis, loss of extremity and
other diseases and conditions
which limit a patient's mobility. | Patients with spinal cord injury,
paralysis, loss of extremity and
other diseases and conditions
which limit a patient's mobility. | Identical to Primary
Predicate. No Impact
on safety or
effectiveness. |
| 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 Primary
Predicate. No Impact
on safety or
effectiveness. |
| 11-40
risc
1
8
S
C
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| 1 |
| ca |
| t |
| 2 |
| œ |
| 1 |
| 1 |
| t |
| 5 |
| e |
| 1 |
| 1 |
| 1 |
-
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| Feature: | Primary Predicate
K021075
RGK Titanium family chairs
(Hi-Lite, Maxima, Ultima, and Style) | Secondary Predicate
K123975
Quickie Q7 Manual Wheelchair | Proposed:
K200135
RGK 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 Predicate
K021075
RGK Titanium family chairs
(Hi-Lite, Maxima, Ultima, and
Style) | Secondary Predicate
K123975
Quickie Q7 Manual Wheelchair | Proposed:
K200135
RGK Aluminum family chairs
(Tiga, Tiga Sub4, Tiga FX, Octane
Sub4, Octane FX, and Hi-Lite) | Description of
Similarities &
Differences |
| 3.3 Drive wheels | Fusion 16 spoke
24" Spinergy SPOX
25" Spinergy SPOX
26" Spinergy SPOX
24" Spinergy LX
25" Spinergy LX
26" Spinergy LX
24" Spinergy BLX
25" Spinergy BLX
26" Spinergy BLX
24" Spinergy CLX
25" Spinergy CLX
26" Spinergy CLX
24" Spinergy XLX
25" Spinergy XLX
26" Spinergy XLX | 20" Mag Wheel 5-Spoke
22" Mag Wheel 5-Spoke
24" Mag Wheel 5-Spoke
20" Lite Spoke Wheel
22" Lite Spoke Wheel
24" Lite Spoke Wheel
25" Lite Spoke Wheel
26" Lite Spoke Wheel
22" Ultra Lightweight Spoke
Wheel
24" Ultra Lightweight Spoke
Wheel
25" Ultra Lightweight Spoke
Wheel
22" Spinergy SPOX Black
24" Spinergy SPOX Black
25" Spinergy SPOX Black
26" Spinergy SPOX Black
22" Spinergy LX Black
24" Spinergy LX Black
25" Spinergy LX Black
26" Spinergy LX Black
24" Mountain | Fusion 16 spoke
24" Spinergy SPOX
25" Spinergy SPOX
26" Spinergy SPOX
24" Spinergy LX
25" Spinergy LX
26" Spinergy LX
24" Spinergy BLX
25" Spinergy BLX
26" Spinergy BLX
24" Spinergy CLX
25" Spinergy CLX
26" Spinergy CLX
24" Spinergy XLX
25" Spinergy XLX
26" Spinergy XLX | Identical to Primary
Predicate. No Impact
on safety or
effectiveness. |
| Feature: | Primary Predicate
K021075 | Secondary Predicate
K123975 | Proposed:
K200135 | Description of
Similarities &
Differences |
| 3.4 Castor Wheels | RGK Titanium family chairs
(Hi-Lite, Maxima, Ultima, and
Style) | Quickie Q7 Manual Wheelchair | RGK Aluminum family chairs
(Tiga, Tiga Sub4, Tiga FX, Octane
Sub4, Octane FX, and Hi-Lite) | |
| | 3" Froglegs Aluminium | 3" Micro | 3" Froglegs Aluminium | Identical to Predicate.
No Impact on safety or
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
Options | Aluminium Hard Anodised
Surge LT
Tetra Grip
Para Grip
Titanium
Stainless steel
Ergo Grip | Aluminum Anodized
Plastic Coated
Natural Fit - Standard Grip
Natural Fit - Super Grip
Natural Fit - No Thumb Grip
Natural Fit LT - Standard Grip
Natural Fit LT - Super Grip
Natural Fit LT - No Thumb Grip
The Surge - Oval w/Gription Strip
The Surge LT - Oval w/ Gription
Strip
Q-Grip Neoprene Coated
Spinorgy Flox Rim | Aluminium Hard Anodised
Surge LT
Tetra Grip
Para Grip
Titanium
Stainless steel
Ergo Grip | Identical to Primary
Predicate. No Impact
on safety or
effectiveness. |
| Feature: | Primary Predicate
K021075 | Secondary Predicate
K123975 | Proposed:
K200135 | Description of
Similarities &
Differences |
| 3.6 Cosmetic | RGK Titanium family chairs
(Hi-Lite, Maxima, Ultima, and
Style)
Product is made from a titanium
frame with a selection of powder
coated colour finished as well as a
satin raw finish. | Quickie Q7 Manual Wheelchair
Product is made from an
aluminum frame with a selection
of powder coated color finishes as
well as some anodized options. | RGK Aluminum family chairs
(Tiga, Tiga Sub4, Tiga FX, Octane
Sub4, Octane FX, and Hi-Lite)
Product is made from an
aluminium frame or titanium
frame with a selection of powder
coated colour finishes as well as
polished and brushed options. | Identical to Primary
and Secondary
Predicates. No impact
on safety or
effectiveness. |
| 3.7 Picture | | | | Substantially
equivalent to Primary
and Secondary
Predicates. No impact
on safety or
effectiveness. |
| 4. Seat: | | | | |
| 4.1 Seat Options | seatplate or seat sling with
cushion | seatplate or seat sling with
cushion | seatplate or seat sling with
cushion | Identical to Primary
and Secondary
Predicates. No impact
on safety or
effectiveness. |
| 4.2 Minimum Seat
Height | 360mm | 330mm rear
400mm front | 360mm | Identical to Primary
Predicate. No impact
on safety or
effectiveness. |
| 4.3 Camber angle | $1^\circ$
$2^\circ$
$3^\circ$ | $0^\circ$
$3^\circ$
$6^\circ$ | $0^\circ$
$1^\circ$
$2^\circ$
$3^\circ$
$5^\circ$ | Substantially
equivalent to Primary
and Secondary
predicates. No impact
on safety or
effectiveness. |
| Feature: | Primary Predicate
K021075 | Secondary Predicate
K123975 | Proposed:
K200135 | Description of
Similarities &
Differences |
| | RGK Titanium family chairs
(Hi-Lite, Maxima, Ultima, and
Style) | Quickie Q7 Manual Wheelchair | RGK Aluminum family chairs
(Tiga, Tiga Sub4, Tiga FX, Octane
Sub4, Octane FX, and Hi-Lite) | |
| COG Adjustment | 25-125mm | 0-100mm | 25-125mm | Identical to Primary
Predicate. No impact
on safety or
effectiveness. |
| Seat Dimensions | Width 250-440mm | Width 300-500mm | Width 300-500mm | Identical to Secondary
Predicate. No Impact
on safety or
effectiveness. |
| | Depth 250-440mm | Depth 300-500mm | Depth 300-500mm | |
| Series | Underseat Scissor
Compact Scissor
Out Front Compact Scissor
Push to Lock
Out Front Push to Lock
Omit Wheel Locks | Direct Mount
High Mount Push
High Mount Pull
Ergo Scissor
Compact
6" Extension Handle Pair | Underseat Scissor
Compact Scissor
Out Front Compact Scissor
Push to Lock
Out Front Push to Lock
Omit Wheel Locks | Identical to Primary
Predicate. No Impact
on safety or
effectiveness. |
| Brakes | | | | |
| Sideguards | Plastic
Aluminium
Aluminium Welded
Aluminium Liftout
Aluminium with Fender
Carbon Fibre
Carbon Fibre with Fender | Plastic - Standard
Plastic - Low
Aluminum
Aluminum with Fender
Carbon Fiber
Carbon Fiber with Fender | Plastic
Aluminium
Aluminium Welded
Aluminium Liftout
Aluminium with Fender
Carbon Fibre
Carbon Fibre with Fender | Identical to Primary
Predicate. No Impact
on safety or
effectiveness. |
| Backrest | Fixed Height
Adjustable Height
Folding Backrest
Ergo Backrest | Non-Folding
Folding Lock-Down Angle
Adjustable
Freestyle Backrest System Non-
Folding
Freestyle Backrest System Folding | Fixed Height
Adjustable Height
Folding Backrest
Ergo Backrest | Identical to Primary
Predicate. No Impact
on safety or
effectiveness. |
7
8
9
10
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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.