(127 days)
Not Found
No
The description details a standard electric mobility scooter with user-controlled speed and braking, and there is no mention of AI or ML components or functionalities.
No.
The device is a mobility aid for transportation, not intended for treating or curing a medical condition.
No
The device is described as a transportation vehicle designed to provide mobility to disabled or elderly persons, not to diagnose any condition.
No
The device description clearly outlines numerous hardware components including a motor, battery, wheels, frame, and control panel, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to disabled or elderly persons. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a transportation vehicle with mechanical and electrical components for movement. There is no mention of analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological markers
- Diagnostic results or interpretations
- Sample collection or processing
The device is clearly a mobility aid, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
It is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
The subject device, Model MS160A scooter is mainly battery-powered and driven by a DC motor, with the speed adjusted by a user-controlled panel.
The motor is driven, and the speed is adjusted by a user-controlled panel and speed knob.
The scooter consists of two folding armrests, a seat cushion, a folding frame, two front wheels, two rear drive wheels with a motor/electromagnetic brake assembly, a rechargeable lithium-ion battery, an off-board battery charger, a control panel, and a motor controller.
The MS160A scooter is designed to provide mobility for people limited to those who walk unchanged or for the elderly.
Folding design: Pull out the seat and backrest fixing pins, push the backrest forward, the seat and backrest fold into each other, release the handlebar locking knob, push the handlebar backward, the handlebar folds down, the whole scooter is folded.
Control panel: Includes speed knob, battery gauge, power key switch, horn button, throttle control lever, headlight switch, charger port, fuse.
Wheel and frame connection method: the motor is connected to the differential, the differential is connected to the frame, the wheels are mounted on both ends of the differential, the motor rotates with the differential, thus driving the scooter.
Frame design:
- The frame of MS160A is aluminum alloy.
- The folding mechanism is operated in two ways:
a. In the non-riding state, pull out the seat fixing pin, push the backrest forward, the seat and backrest can be folded.
b. Loosen the handlebar locking knob, push the handlebar forward, the handlebar will fold down.
The front wheels of the scooter are 7 inches and the rear wheels are 10 inches.
The motor of the scooter is ST-62D24-120W; the lithium-ion battery is 25.55V 10.4AH; the charger is 24V/2A.
Max. loading cannot be over than 125kg.
The maximum distance travelled with a fully charged battery is 8.2km and the maximum forward speed is 1.8m/s.
Braking time is about 2 seconds, braking distance is
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below that.
January 31, 2025
Suzhou Master Machinery Manufacturing Co., Ltd. % Boyle Wang Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China
Re: K242982
Trade/Device Name: Mobility Scooter (MS160A) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: January 3, 2025 Received: January 3, 2025
Dear Boyle Wang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Mobility Scooter (MS160A)
Indications for Use (Describe)
It is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
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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4
510(k) Summary
K242982
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's information
Name: Suzhou Master Machinery Manufacturing Co., Ltd. Address: 2/F, Block B, No. 379, Delan Industrial Park, Zhangpu Town, Kunshan City, Jiangsu Province, China. Tel: 86-512-57452882 Fax: 86-512 - 57452992 Contact: Siqi.Shangquan Date of Preparation: Aug.09, 2024
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Mobility Scooter Common name: Scooter Classification name: Motorized Three-Wheeled Vehicle Model(s): MS160A
3.0 Classification
Production code: INI Regulation number: 21 CFR 890.3800 Classification: Class II Panel: Physical Medicine
4.0 Predicate device information
Manufacturer: Nanjing Jin Bai He Medical Apparatus Co., Ltd. Trade/Device: Scooter (Model: FDB01) 510(k) number: K201196
5
5.0 Indication for Use Statement
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
6.0 Device description
The subject device, Model MS160A scooter is mainly battery-powered and driven by a DC motor, with the speed adjusted by a user-controlled panel.
The motor is driven, and the speed is adjusted by a user-controlled panel and speed knob.
The scooter consists of two folding armrests, a seat cushion, a folding frame, two front wheels, two rear drive wheels with a motor/electromagnetic brake assembly, a rechargeable lithium-ion battery, an off-board battery charger, a control panel, and a motor controller.
The MS160A scooter is designed to provide mobility for people limited to those who walk unchanged or for the elderly.
Folding design: Pull out the seat and backrest fixing pins, push the backrest forward, the seat and backrest fold into each other, release the handlebar locking knob, push the handlebar backward, the handlebar folds down, the whole scooter is folded.
Control panel: Includes speed knob, battery gauge, power key switch, horn button, throttle control lever, headlight switch, charger port, fuse.
Wheel and frame connection method: the motor is connected to the differential, the differential is connected to the frame, the wheels are mounted on both ends of the differential, the motor rotates with the differential, thus driving the scooter.
Frame design:
-
The frame of MS160A is aluminum alloy.
-
The folding mechanism is operated in two ways:
a. In the non-riding state, pull out the seat fixing pin, push the backrest forward, the seat and backrest can be folded.
b. Loosen the handlebar locking knob, push the handlebar forward, the handlebar will fold down.
The front wheels of the scooter are 7 inches and the rear wheels are 10 inches.
The motor of the scooter is ST-62D24-120W; the lithium-ion battery is 25.55V 10.4AH; the charger is 24V/2A.
Max. loading cannot be over than 125kg.
The maximum distance travelled with a fully charged battery is 8.2km and the maximum forward speed is 1.8m/s.
Braking time is about 2 seconds, braking distance is ≤1.5 meters.
6
7.0 Summary of Non-Clinical Testing_
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs
ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed,
acceleration and deceleration of electric wheelchairs
ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ISO 7176-11: 2012 Wheelchairs - Part 11: Test dummies
ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
EN 12184 :2014 Electrically powered wheelchairs, scooters and their chargers-Requirements and test methods
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests IEC TR 60601-4-2 Medical electrical equipment – Part 4-2: Guidance and
interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
Biocompatibility of patient-contacting parts
7
Patient-contacting material are carried out biocompatibility assessment in accordance with ISO 10993-1: 2018, including:
Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
Skin Sensitization per ISO 10993-10:2021 Biological Evaluation of Medical Devices -Part 10: Tests For Skin Sensitization.
Irritation per ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 23: Tests For Irritation.
8.0 Summary of Clinical Testing
No clinical study implemented for the scooter.
9.0 Technological Characteristic Comparison Table
| Table 1 - General Comparison | |||
|---|---|---|---|
| Item | Subject device | Predicate device | |
| K201196 | Remark | ||
| Product Code | INI | INI | Same |
| Regulation No. | 21 CFR 890.3800 | 21 CFR 890.3800 | Same |
| Class | II | II | Same |
| Product name | Scooter (Model: MS160A) | Scooter (Model: FDB01) | - |
| 510(k) No. | K242982 | K201196 | - |
| Intended | |||
| Use/Indication | |||
| n for Use | It is a motor driven, indoor and | ||
| outdoor transportation vehicle | |||
| with the intended use to provide | |||
| mobility to a disabled or elderly | |||
| person limited to a seated | |||
| position. | It is a motor driven, indoor | ||
| and outdoor transportation | |||
| vehicle with the intended use | |||
| to provide mobility to a | |||
| disabled or elderly person | |||
| limited to a seated position. | Same | ||
| Use environment | Indoor and outdoor use | Indoor and outdoor use | Same |
| Patient | |||
| Population | This product is suitable for | ||
| disabled people with mobility | |||
| difficulties and elderly people. | This product is suitable for | ||
| disabled people with mobility | |||
| difficulties and elderly people. | Same | ||
| Product structure | It has a base with frame, two | ||
| front wheels, two rear wheels, | |||
| two anti-tip wheels, a seat, a | |||
| tiller, a control panel, an electric | |||
| motor, an electromagnetic | |||
| brake, a rechargeable | |||
| Lithium-Ion Battery with a | |||
| charger. | It has a base with metal alloy | ||
| frame, two front wheels, two | |||
| rear wheels, two anti-tip | |||
| wheels, a seat, an adjustable | |||
| steering column, a tiller | |||
| console, an electric motor, an | |||
| electromagnetic brake, 2 | |||
| rechargeable Lithium-Ion | |||
| Battery with an off-board | Similar |
Table 1 - General Comparison
8
| charger. | |||
|---|---|---|---|
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Number of | |||
| wheels | 4 | 4 | Same |
| Main frame | |||
| material | Aluminium alloy | Aluminium alloy | Same |
| Motor | Brushless motor, | ||
| DC24V * 120W * 1 pcs | brush differential rear axle. | ||
| 24V * 180W | Minor differences in the | ||
| dimensions will not | |||
| impact the safety and | |||
| effectiveness of the | |||
| substantial equivalence. | |||
| Battery | DC 25.55V 10.4Ah Lithium-ion, | ||
| 1 pc | 24V 6AH Lithium-ion, | ||
| 2 pcs | |||
| Battery charger | Off-board charger | ||
| Input: 100-240 VAC | |||
| Output: DC 24V, 2A | Off-board charger | ||
| Input: 100-240 VAC | |||
| Output: DC 24V, 6 Amp |
Table 2 - Performance Comparison
| Item | Subject Device | Predicate Device
K201196 | Remark |
|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions
(mm) | 1000 x 540 x 900 | 1050 x 550 x 870 | Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Folded
dimensions
(mm) | 1000 x 540 x 410 | 480 x 550 x790 | Minor differences in the folded dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Weight, w/
Battery | 48.5lbs. /22kg | 63.1lbs. /29 kg | The difference will not raise any new safety and effectiveness concerns. |
| Frame design | Foldable/
Electric scooter is driven by
electricity scooter, is a
transportation tool and auxiliary
tools for the purpose of walking,
without removing the battery can be
folded, easy to carry and storage. | Foldable/
Electric scooter is driven by
electricity scooter, is a
transportation tool and
auxiliary tools for the
purpose of walking, without
removing the battery can be
folded, easy to carry and
storage. | Same |
| Seating
Design | In non-riding state, pull out the seat
fixing pin, push forward the
backrest, the seat and backrest can
be folded. | One-click folding
intelligent electric scooter,
with a sensitive remote
control, gently press, the | The difference will not raise any new safety and effectiveness concerns. |
| | | | |
| | Loosen the handlebar locking knob,
push forward the handlebar, the
handlebar will be folded down. | car automatically
completed folding
contraction, folding volume
small, electromagnetic
automatic brake, the overall
simple design, convenient
and practical, Travel does not
have to consume physical
force to do folding, poor
physical strength and the
elderly the best walking
tool. | |
| Seating
Attachment -
integrated,
power base,
specialty
power | Without any seat accessories
(integrated, power base, dedicated
power supply) | Without any seat accessories
(integrated, power base,
dedicated power supply) | Same |
| Folding
mechanism | A foldable seat frames
(The backrest could be folded to
seat) | Seat can be folded; battery
can be dismantled; The frame
can be folded back and forth | Same |
| Front
wheel(inch) | 7
(Solid tire) | 7
(Solid tire) | Same |
| Rear tire (inch) | 10
(Solid tire) | 8
(Solid tire) | Larger size of rear wheels
bring steadier pivoting
function than predicate
device. |
| Anti-tip Wheels
(inch) | 2.5 | 2.5 | Same |
| Cruising
Range(km) | 8.2 | Not Publicly Available | The difference will not raise
any new safety and
effectiveness concerns. |
| Obstacle
climbing(mm) | 15 | 60 | The smaller height in the
obstacle climbing will not
impact the safety and
effectiveness of the subject
device. |
| Ground
clearance | 94mm | 50mm | The device has been tested
according to ISO7176 series
standards and the test
records support its safety and
effectiveness. |
| Static stability | 40° | 30° | Both of the devices are |
| forward | | | evaluated according to |
| Static stability
rearward | 14.5° | 20.1° | standard ISO 7176-1:2014,
so the different static stability |
| Static stability
sideways | 18° | 15.3° | will not impact the safety and
effectiveness |
| Max. loading
(kg) | 275lbs(125kg) | 265lbs (120kg) | Similar
The difference will
not raise any new safety
and effectiveness
concerns. |
| Maximum safe
operational
incline | Maximum safe operational incline
for posteriorly is >40
Maximum safe operational incline
for anteriorly is 14.5°
Maximum safe operational incline
for sideways is 18° | Maximum safe operational
incline for posteriorly is 20.1°
Maximum safe operational
incline for anteriorly is 30°
Maximum safe operational
incline for sideways is 15.3° | Larger safe operational
incline of subject brings more
convenient for the use
environment |
| Min. Turning
radium | 1500mm | 1200mm | The little difference in the
turning radius will bring more
convenience when it turns.
The difference will not raise
any new safety and
effectiveness concerns. |
| Minimum
braking
distance | 1.2m for the speed of 6.4km/h
1 s | 1.1 m for the speed of 6km/h
1 s | Similar |
| Max Speed
Forwards | 1.8 m/s (6.4 km/h) | 1.67m/s (6 km/h) | The devices are evaluated
according to standard ISO
7176-6:2018, so the different
will not impact the safety
and effectiveness |
| Max. Speed
Backward | 0.7 m/s (2.5 km/h) | 0.83m/s (3 km/h) | The devices are evaluated
according to standard ISO
7176-6:2018, so the different
will not impact the safety and
effectiveness |
| Controller | Yangzhou Jinnew Electronic
Technology co., ltd.
FY05-7-F | British PG Controller
PG45A | Although different controller
is used, both the control
system, including the
electromagnetic brakes and
the user interface are similar.
Both devices have the same
user interface, the patient
uses the foldable tiller
handle/handlebar for steering |
| | | | and a thumb operated |
| | | | potentiometer throttle control |
| | | | lever located at the top of the |
| | | | tiller to engage and |
| | | | disengage the scooter motion |
| | | | in both the forward and |
| | | | reverse directions. When the |
| | | | throttle control lever is |
| | | | released, the electromagnetic |
| | | | brake will be actuated and |
| | | | the scooter is slow to stop. |
| | | | The speed mode of the both |
| | | | devices was single mode and |
| | | | the speed control dial can |
| | | | control the maximum speed. |
| | | | Both of the control systems |
| | | | are evaluated according to |
| | | | standard ISO 7176-14:2008 |
| | | | and software validation |
| | | | requirement and there are no |
| | | | new safety and effectiveness |
| | | | concerns due to the |
| | | | difference. |
| Wheel
Lock
(type) | Electromagnetic brake | Electromagnetic brake | Same |
9
10
11
Table 3 - Safety Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Materials | |||
| contacting user | Hand grips: PVC; | Armrest: PU Foamed; | Biocompatibility |
| evaluation has | |||
| been carried out | |||
| per ISO 10993-1. | |||
| There are no new | |||
| safety and | |||
| effectiveness | |||
| concern due to the | |||
| difference. | |||
| Backrest (Back support): PVC, sponge; | Backrest/seat: Leather package | ||
| Armrest (Arm support): PVC, sponge; | Footplates: ABS plastics | ||
| Seat: PVC, sponge; | |||
| Foot support pad: PEVA; | |||
| Throttle controller lever: ABS. | |||
| Biocompatibility | |||
| of materials | |||
| contacting user | Comply with ISO 10993-1, FDA | ||
| Guidance, Tests included: | Comply with ISO 10993-1, FDA | ||
| Guidance, Tests included: | Same | ||
| Cytotoxicity (ISO 10993-5:2009), | Cytotoxicity (ISO 10993-5:2009), | ||
| Skin Sensitization test (ISO | |||
| 10993-10:2021) | Sensitization and Intracutaneous | ||
| Reactivity (ISO 10993-10:2010) | |||
| Intracutaneous Reacitivity Test (ISO | |||
| 10993-23:2021) |
12
Summary of substantial equivalence discussion:
Despite of the above differences, the two devices all completed the performance tests in accordance with ISO 7176 series standards. There are no safety and effectiveness aspects concerned. In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the subject device K242982 is as safe, as effective, and performs as well as the legally marketed predicated device in K201196 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.