(22 days)
Not Found
No
The device description details a standard powered wheelchair with a joystick control and motorized seating adjustments. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
A therapeutic device is generally defined as one that is used to treat, cure, mitigate, or prevent disease. This device is a powered wheelchair intended for mobility assistance, which falls under assistive devices, not therapeutic devices.
No
The Merits P335 Powered Wheelchair is designed to provide mobility, not to diagnose a medical condition or disease.
No
The device description clearly details a physical powered wheelchair with hardware components such as motors, batteries, frame, wheels, and actuators. While it includes a controller and user interface (joystick), the core of the device is a physical mobility aid, not solely software.
Based on the provided text, the Merits P335 Powered Wheelchair is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for providing mobility to individuals with limited seating capabilities. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a mechanical and electrical device for transportation, including a frame, motors, batteries, and controls. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing diagnostic information about a disease or condition
The device is clearly a mobility aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Merits P335 Powered Wheelchair is intended to provide indoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The Merits P335 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the PG power wheelchair R-net 120 amp controller. The user interface is a joystick. P335 is powered by two 12 VDC 60ah batteries. The batteries are charged by 6A off-board charger connect with 3-pin Microphone Connector to charging socket on joystick. The approximate driving range on fully charged batteries is up to 30km (19mi). The chair frame is a welded steel construction and includes two front drive wheels with drive units (including motor, gear, and brake), batteries and rear pivoting casters. Depending on users' needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the wheelchair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.
The device is equipped with a Power Seating System consists of a power tilt unit, a power recline module and an optional power elevating seat module. The tilt, reclining and elevating systems are actuated by 24V DC motorized linear actuator. The tilt system includes one motorized linear actuator caused the seat frame to shift forward. This enhances stability since the center of gravity is kept substantially in place while the user is tilting. The recline system include one motorized linear actuator change the position of the backrest with respect to the seat pan. The optional elevating seat module use one motorized linear actuator which allows the user to elevate the seat pan for easy accessing things stored in higher places.
The upholstery of the device complies with ISO 7176-16:2012: Wheelchairs -- Part 16: Resistance to ignition of postural support devices.
The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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 Non-clinical Tests have been Performed in support of the substantial equivalence determination:
- ISO 7176-1:2014 Determination of Static Stability
- ISO 7176-2:2017 Determination of Dynamic Stability of electric wheelchairs
- ISO 7176-3:2012 Determination of effectiveness of brakes
- ISO 7176-4:2008 Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- ISO 7176-5:2008 Determination of overall dimensions, mass and maneuvering space
- ISO 7176-6:2018 Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- ISO 7176-7:1998 Method of Measurement of Seating and Wheel Dimensions
- ISO 7176-8:2014 Requirements and test methods for static, impact and fatigue strengths
- ISO 7176-9:2009 Climatic tests for wheelchairs
- ISO 7176-10:2008 Determination of obstacle-climbing ability of electrically power wheelchairs
- ISO 7176-11:2012 Test dummies
- ISO 7176-13:1989 Determination of coefficient of friction of test surfaces
- ISO 7176-14:2008 Power and control systems for electrically powered wheelchairs and scooter- Requirements and test methods.
- ISO 7176-15:1996 Requirements for Information Disclosure, Documentation and Labeling
- ISO 7176-16:2012 Resistance to ignition of postural support devices
- ISO 7176-21:2009 Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers.
- ISO 7176-25:2013 Batteries and charger for powered wheelchairs
- ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- IEC60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
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.
Permobil F3 FWD Powered Wheelchair (#K143180)
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
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 18, 2022
Merits Health Products Co., LTD. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K220529
Trade/Device Name: Merits P335 Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 20, 2022 Received: February 24, 2022
Dear Mr. Yungvirt:
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
1
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 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 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
Enclosure
2
Indications for Use
510(k) Number (if known) K220529
Device Name Merits P335 Powered Wheelchair
Indications for Use (Describe)
The Merits P335 Powered Wheelchair is intended to provide indoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY - K220529
I. Submitter:
Merits Health Products Co., LTD. No.18, Jingke Rd., Nantun Dist. Taichung City 40852, Taiwan (R.O.C.)
Phone: +886-4-23594985 ext.200 Fax: +886-4-23594992
Contact Person: Martin Tseng Date Prepared: November 26, 2021
II. Device:
Name of Device: Merits P335 Powered Wheelchair Common or Usual Name: Powered Wheelchair Classification Name: Powered Wheelchair (21 CFR 890.3860) Regulatory Class: II Product Code: ITI
III. Predicate Device:
Permobil F3 FWD Powered Wheelchair (#K143180) This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. Device Description:
The Merits P335 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the PG power wheelchair R-net 120 amp controller. The user interface is a joystick. P335 is powered by two 12 VDC 60ah batteries. The batteries are charged by 6A off-board charger connect with 3-pin Microphone Connector to charging socket on joystick. The approximate driving range on fully charged batteries is up to 30km (19mi). The chair frame is a welded steel construction and includes two front drive wheels with drive units (including motor, gear, and brake), batteries and rear pivoting casters. Depending on users' needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the wheelchair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.
The device is equipped with a Power Seating System consists of a power tilt unit, a power recline module and an optional power elevating seat module. The tilt, reclining and elevating systems are actuated by 24V DC motorized linear actuator. The tilt system includes one motorized linear actuator caused
4
the seat frame to shift forward. This enhances stability since the center of gravity is kept substantially in place while the user is tilting. The recline system include one motorized linear actuator change the position of the backrest with respect to the seat pan. The optional elevating seat module use one motorized linear actuator which allows the user to elevate the seat pan for easy accessing things stored in higher places.
The upholstery of the device complies with ISO 7176-16:2012: Wheelchairs -- Part 16: Resistance to ignition of postural support devices.
The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
The Merits P335 is substantially equivalent to Permobil F3 FWD Powered Wheelchair (#K143180). Both products are battery power, motorized vehicles designed for use as personal power mobility aids. Performance characteristics and drive mechanisms are similar and all have the same intended function and use which is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair. Additional, they are all constructed from the same basic materials, have the same basic operational principles and all use DC batteries as their source of power.
Although there are some minor differences between P335 and its predicate device. But they raise no new issues of safety or effectiveness. Performance data demonstrate that Merits P335 is safe. The non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do no raise any new questions of safety or effectiveness.
V. Indications for Use:
The Merits P335 Powered Wheelchair is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
The Indications for Use for the Merits P335 is identical to the predicate device.
VI. Comparison of Technological Characteristics with The Predicate Device:
The Merits P335 Powered Wheelchair is substantially equivalent to the Permobil F3 Powered Wheelchair (K143180). Both products are battery power, motorized vehicles designed for use as personal power mobility aids. Performance characteristics and drive mechanisms are similar and all have the same intended function and use. The detailed comparison table is as follow:
| Description | Merits P335 Power Wheelchair
K220529 | Permobil F3 Powered Wheelchair
K143180 |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Merits Health Products Co., LTD. | Permobil AB |
| Model | P335 | F3 |
| Intended Use | To provide indoor and outdoor
mobility to persons limited to a
seating position that are capable
of operating a powered
wheelchair. | To provide indoor and outdoor
mobility to persons limited to a
seating position that are capable
of operating a powered
wheelchair. |
5
| Framework | Steel welded frame | Steel welded frame | |
|---|---|---|---|
| Overall | |||
| Dimensions | Length | 39.6" (±0.6") | 40" |
| Width | 24.7" (±0.6") | 24" | |
| Height | 42" (±0.6") | 38" | |
| Seat | |||
| Dimensions | Width | 14~22" (±0.6") | 17~23" |
| Depth | 18" (±0.6") | 18" | |
| Height | 17.5~19.5" (±0.6") From Ground | 17.5~19.5" From Ground | |
| Weight | Total | 386.1lb | 386 lb |
| Base | 147 lb | 169 lb | |
| Seat | 122 lb | 140 lb | |
| Footplate | 40.1lb | ||
| Battery | 38.5lb*2pcs | 38.5lb*2pcs | |
| Unit Configuration | Front Wheel Drive | Front Wheel Drive | |
| Weight Capacity | 300 lb | 300 lb | |
| Gradient | 7.5° | 6° | |
| Obstacle Climbing | 2.4"(60mm) | 2.4"(60mm) | |
| Turning Radius | 26.6" | 26.6" | |
| Ground Clearance | 3" | 3" | |
| Drive Wheel Tires | O.D.=355.6mm (14") Foam Filled | ||
| Tire | O.D.=355.6mm (14") Foam Filled | ||
| Tire | |||
| I.D.=203.2mm (8") | |||
| Width=76.2mm(3") | I.D.=203.2mm (8") | ||
| Width=76.2mm(3") | |||
| Caster Tires | 225x70 mm (9”) Foam Filled Tire | 210x65 mm (8") Foam Filled Tire | |
| Anti-Tip Wheel | 100x24 mm (4") Non-Removable | 100x24 mm (4") Non-Removable | |
| Suspension | Front/ Rear Gas Spring | Front/ Rear Gas Spring | |
| Max. Speed | 6 mph | 6 mph | |
| Range up to | 19miles | 20 miles | |
| Brake System | Electronic braking by drive motor. | ||
| Magnetic parking brakes | Electronic braking by drive motor. | ||
| Magnetic parking brakes | |||
| Motor | 2 Pole, 24Vdc Motor | 2 Pole, 24Vdc Motor | |
| Controller | PG R-net 120A | PG R-net 120A | |
| Battery | 2*12V 60Ah Lead Acid Battery | 2*12V 60Ah Lead Acid Battery | |
| Type: Off-board charger | Type: Off-board charger | ||
| Charger | Input: 100-240Vac, 50/60Hz, 2.5A | Input: 100-240Vac, 50/60Hz, 3.8A | |
| Output: 6A /24Vdc | Output: 8A /24Vdc | ||
| Footplate | Yes | Yes | |
| Tilt | Yes | Yes | |
| Recline | Yes | Yes | |
| Elevate | Optional | Optional | |
| Backrest Cover | Vinyl Fabric | Vinyl Fabric | |
| Backrest Upholstery | PU Foam | PU Foam | |
| Cushion cover | Vinyl Fabric | Vinyl Fabric | |
| Cushion Upholstery | PU Foam | PU Foam | |
| Armrest Type | PU Foam | PU Foam |
There are some differences between P335 and its predicate device:
- a. Dimension: The dimensions of the Merits P335 is equivalent in size to the Premobil F3 (K143180). Although there are some differences, the device passed ISO 7176-1 (Determination of Static Stability) and ISO 7176-2 (Determination of Dynamic Stability of electric wheelchairs). So there is no deleterious affection of safety and effectiveness about the difference on Dimension with predicated device.
- b. Gradient: The Merits P335 has a larger Gradient than the Permobil F3 (K143180). The device has passed ISO 7176-2 (Determination of Dynamic
6
Stability of electric wheelchairs) & ISO 7176-3 (Determination of Efficiency of Brake of Electric Wheelchair) test. So there is no deleterious affection of safety and effectiveness about the difference on Gradient with predicated device.
- c. Rear Caster size: The Merits P335 is equipped with 2 larger 9" Casters. which give the same or better curb climbing ability than the Permobil F3 (#K143180) 8" Castors while moving backward. There is no deleterious affection of safety and effectiveness about the difference on Rear Castor size with predicated device.
- d. Weight: Although the total weight of P335 is slightly heavier than Permobil F3 Powered Wheelchair (K143180). The device has passed ISO 7176-8 (Requirements and test methods for static, impact and fatigue strengths) test. So there is no deleterious affection of safety and effectiveness about the difference on Weight with predicated device.
- e. Charger: The Merits P335 uses a 6A off-board charger which is smaller than the 8A off-board charger used on Permobil F3 (K143180). This will slightly increase the charging time needed for the same 60Ah batteries. But the charger has passed the ISO 7176-25 (Batteries and charger for powered wheelchairs) test. So there is no deleterious affection of safety and effectiveness about the difference on charger with predicated device.
The minor differences between P335 and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the P335 is safe.
The non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do no raise any new questions of safety or effectiveness.
7
VII. Performance Data
The following Non-clinical Tests have been Performed in support of the substantial equivalence determination:
| STD No. | Title of Standard | FDA Rec. No. |
|---|---|---|
| ISO 7176-1:2014 | Determination of Static Stability | 16-195 |
| ISO 7176-2:2017 | Determination of Dynamic Stability of electric | |
| wheelchairs | 16-202 | |
| ISO 7176-3:2012 | Determination of effectiveness of brakes | 16-192 |
| ISO 7176-4:2008 | Energy consumption of electric wheelchairs and | |
| scooters for determination of theoretical distance | ||
| range | 16-162 | |
| ISO 7176-5:2008 | Determination of overall dimensions, mass and | |
| maneuvering space | 16-163 | |
| ISO 7176-6:2018 | Determination of maximum speed, acceleration and | |
| deceleration of electric wheelchairs | 16-204 | |
| ISO 7176-7:1998 | Method of Measurement of Seating and Wheel | |
| Dimensions | 16-196 | |
| ISO 7176-8:2014 | Requirements and test methods for static, impact and | |
| fatigue strengths | 16-197 | |
| ISO 7176-9:2009 | Climatic tests for wheelchairs | 16-167 |
| ISO 7176-10:2008 | Determination of obstacle-climbing ability of | |
| electrically power wheelchairs | 16-164 | |
| ISO 7176-11:2012 | Test dummies | 16-190 |
| ISO 7176-13:1989 | Determination of coefficient of friction of test surfaces | 16-25 |
| ISO 7176-14:2008 | Power and control systems for electrically powered | |
| wheelchairs and scooter- Requirements and test | ||
| methods. | 16-165 | |
| ISO 7176-15:1996 | Requirements for Information Disclosure, | |
| Documentation and Labeling | 16-27 | |
| ISO 7176-16:2012 | Resistance to ignition of postural support devices | 16-191 |
| ISO 7176-21:2009 | Requirements and test methods for electromagnetic | |
| compatibility of electrically powered wheelchairs and | ||
| scooters, and battery chargers. | 16-166 | |
| ISO 7176-25:2013 | Batteries and charger for powered wheelchairs | 16-194 |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: | |
| Evaluation and testing within a risk management | ||
| process | 2-258 | |
| IEC60601-1-2:2020 | Medical electrical equipment - Part 1-2: General | |
| requirements for basic safety and essential | ||
| performance - Collateral Standard: Electromagnetic | ||
| disturbances - Requirements and tests | 19-36 |
The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
8
Biocompatibility Evaluation
A Biocompatibility Evaluation has been performed according to the ISO 10993-1:2018. As the skin contact components listed below are identical to those used on our premarket devices in formulation, processing sterilization and geometry, and no other chemical have been added (e.q. plasticizers, fillers, color additives, cleaning agents, mold release agents). There is no need for any more Biocompatibility tests.
| | Merits
P335 | Merits
P322 | Merits
Model R Series | Same or
Different |
|-------------------------------------|----------------------------------|----------------------------------|-------------------------------------|----------------------|
| K Number | K220529 | K122357 | K113577 | N/A |
| Product Code | ITI | ITI | ITI | Same |
| Seat Cushion:
Supplier: | Vinyl Fabric
ROODINSEAT Corp. | Vinyl Fabric
ROODINSEAT Corp. | Vinyl Fabric
ROODINSEAT
Corp. | Same |
| Backrest Cushion:
Supplier: | Vinyl Fabric
ROODINSEAT Corp. | Vinyl Fabric
ROODINSEAT Corp. | Vinyl Fabric
ROODINSEAT
Corp. | Same |
| Armrest Pad
Material: Supplier: | PU Foam
WELL YI CO., LTD. | PU Foam
WELL YI CO., LTD. | PU Foam
WELL YI CO., LTD. | Same |
| Footrest Pad
Material: Supplier: | PU Foam
WELL YI CO., LTD. | PU Foam
WELL YI CO., LTD. | PU Foam
WELL YI CO., LTD. | Same |
VIII. Conclusions
According to comparison table, the differences on function of elevate, recline and dimension of width do not deleteriously affect the safety and effectiveness of the device.
So based on the design, performance specifications and testing and intended use, the Merits P335 Powered Wheelchair is substantially equivalent to Permobil F3 FWD Powered Wheelchair (#K143180).