(201 days)
Not Found
No
The device description and performance studies focus on standard mobility scooter features and safety standards, with no mention of AI or ML.
No.
The device is a mobility scooter intended to provide mobility to persons restricted to a sitting position. While it aids in daily living, it does not treat or cure a disease, or restore damaged tissue, nor does it perform a function that would make it a therapeutic device. It helps with a disability (limited mobility) but is not "therapeutic" in the medical sense.
No
The "Intended Use / Indications for Use" states that the device is intended "to provide mobility to persons restricted to a sitting position," which describes a mobility aid, not a device used for diagnosis.
No
The device description clearly outlines a physical mobility scooter with hardware components such as wheels, a seat, a tiller, a control panel, and a battery. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to persons restricted to a sitting position. This is a physical function, not a diagnostic one.
- Device Description: The description details a mobility scooter with wheels, a seat, controls, and a battery. There is no mention of components or functions related to testing samples from the human body (like blood, urine, tissue, etc.) for diagnostic purposes.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples.
- Detection or measurement of substances in the body.
- Diagnosis, monitoring, or screening of diseases or conditions.
- Performance metrics like sensitivity, specificity, etc., which are relevant to diagnostic accuracy.
The device described is a mobility aid, falling under a different category of medical devices.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
WT-T4QP2 is for indoor or outdoor uses, and it is Lithium-ion battery powered and configured with four solid wheels, a seat, a turning tiller, and a control panel.
WT-T4QP2 is driven by two PU solid rear wheels (7.28" x 1.96") and steered by two PU solid castors (6.49" x 1.96"). The user can control the turning tiller to control the castors to steer the scooter's direction. Control panel has 3 functions of battery level indication, speed lever and forward/reverse selector. The user can pull the speed lever to drive forward or drive backward. Release the speed lever completely and the electromagnetic brake in the motor will be activated automatically, and the scooter will stop.
The maximum weight capacity of WT-T4QP2 is 250 lbs. (115 kg). Its maximum forward speed is 4 mph (6.4 km/h), and its maximum safe climbing incline angle is 6 degrees.
The following surfaces are recommended NOT to operate on:
- Sand surface
- Wet or icy surface
- Road maintenance hole metal cover
- Avoid going up multiple steps.
- Avoid using escalators. Use the elevator.
- Too steep incline over 6 degrees.
- Ground clearance to battery over 1.1"/28 mm
- Curb climbing ability over 1.58"/40 mm
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)
Performance Testing:
- ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability, 1999.
- ISO 7176-2:2017 Wheelchairs Part 2: Determination of dynamic stability of ● electric 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 for determination of theoretical distance range,
- ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and maneuvering space,
- ISO 7176-6:2001 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs,
- ISO 7176-7:1998 Wheelchairs - Part 7: Determination of seating dimensions -Definitions and measuring method,
- ISO 7176-8:1998 Wheelchairs - Part 8: Static, impact and fatigue strength for manual wheelchairs.
- 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 7176-16: 2012 Wheelchairs – Part 16: Resistance to ignition of postural support devices
- RESNA WC-2:2019 Section 14 Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
- RESNA WC-2:2019 Section 21 Requirements and test method electromagnetic compatibility of powered wheelchairs and motorized scooters.
Biocompatibility evaluation per ISO 10993-1:2018
- Handle bar grip: DIOSHY TPV, Tests conducted: Cytotoxicity, Sensitization and Irritation tests, Verdict: Pass
- Seat: PU, Tests conducted: Cytotoxicity, Sensitization and Irritation tests, Verdict: Pass
- Speed lever: PVC (NAN YA FR-PA66), Tests conducted: Cytotoxicity, Sensitization and Irritation tests, Verdict: Pass
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
§ 890.3800 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 contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 28, 2023
Wu's Tech Co., Ltd. % Dr. Jen Ke-Min Contact Person Chinese European Industrial Research Society No. 58. Fu-Chiun St Hsin-Chu City, Taiwan 300113 Taiwan
Re: K222729
Trade/Device Name: Electrical Scooter, WT-T4QP2 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: February 17, 2023 Received: February 27, 2023
Dear Dr. Jen Ke-Min:
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.
1
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 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.
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
2
Indications for Use
510(k) Number (if known) K222729
Device Name Electric Scooter, WT-T4QP2
Indications for Use (Describe)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting 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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3
510(k) number: K222729
510(k) Summary (per 21 CFR 807.92)
| Submitter's Name: | Wu's Tech Co., Ltd.
No.225, Yuan Peir St., Hsinchu, Taiwan ROC 30093 |
|------------------------|-------------------------------------------------------------------------|
| Date summary prepared: | August 28, 2022 |
| Proprietary Name: | Electrical Scooter, model WT-T4QP2 |
| Common or Usual Name: | Electrical Scooter |
| Classification Name | Motorized Three-Wheeled Vehicle,
Class II, 21 CFR 890.3800 |
| Product Code: | INI |
| Contact Person | Dr. KE-MIN JEN (email: ceirs.jen@msa.hinet.net)
TEL: 886-3-5208829 |
| Predicate Device | PUC Perfect Union Co., Ltd. |
| Device name | i3 Foldable Mobility Scooter |
| 510(k) Number | K191356 |
● Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
● Device Description:
WT-T4QP2 is for indoor or outdoor uses, and it is Lithium-ion battery powered and configured with four solid wheels, a seat, a turning tiller, and a control panel.
WT-T4QP2 is driven by two PU solid rear wheels (7.28" x 1.96") and steered by two PU solid castors (6.49" x 1.96"). The user can control the turning tiller to control the castors to steer the scooter's direction. Control panel has 3 functions of battery level indication, speed lever and forward/reverse selector. The user can pull the speed lever to drive
4
forward or drive backward. Release the speed lever completely and the electromagnetic brake in the motor will be activated automatically, and the scooter will stop.
The maximum weight capacity of WT-T4QP2 is 250 lbs. (115 kg). Its maximum forward speed is 4 mph (6.4 km/h), and its maximum safe climbing incline angle is 6 degrees.
The following surfaces are recommended NOT to operate on:
- � Sand surface
- Wet or icy surface �
- Road maintenance hole metal cover �
- � Avoid going up multiple steps.
- � Avoid using escalators. Use the elevator.
- Too steep incline over 6 degrees.
- Ground clearance to battery over 1.1"/28 mm
- Curb climbing ability over 1.58"/40 mm
Performance Testing: ●
- ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability, 1999.
- ISO 7176-2:2017 Wheelchairs Part 2: Determination of dynamic stability of ● electric 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 for determination of theoretical distance range,
- ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and maneuvering space,
- ISO 7176-6:2001 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs,
- ISO 7176-7:1998 Wheelchairs - Part 7: Determination of seating dimensions -Definitions and measuring method,
- ISO 7176-8:1998 Wheelchairs - Part 8: Static, impact and fatigue strength for manual wheelchairs.
- ISO 7176-9:2009 Wheelchairs Part 9: Climatic tests for electric wheelchairs, ●
5
- ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs,
- ISO 7176-16: 2012 Wheelchairs – Part 16: Resistance to ignition of postural support devices
- RESNA WC-2:2019 Section 14 Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
- RESNA WC-2:2019 Section 21 Requirements and test method electromagnetic compatibility of powered wheelchairs and motorized scooters.
| Patient-contacting
Parts | Materials | Rational according
to
Wu's Tech expertise | Tests conducted | Verdict |
|-----------------------------|----------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|---------|
| Handle bar grip | DIOSHY
TPV | No customer
claim with
adverse
conditions for
more than 300
thousand units in
the market. | Cytotoxicity,
Sensitization
and Irritation
tests | Pass |
| Seat | PU | No customer
claim with
adverse
conditions for
more than 300
thousand units in
the market. | Cytotoxicity,
Sensitization
and Irritation
tests | Pass |
| Speed lever | PVC
(NAN YA
FR-PA66) | No customer
claim with
adverse
conditions for
more than 250
thousand units in
the market. | Cytotoxicity,
Sensitization
and Irritation
tests | Pass |
Biocompatibility evaluation per ISO 10993-1:2018 ●
6
Comparison table ●
| | Devices
Specifications | Subject device | Predicate device | Comparison
verdict |
|-------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------|
| | Manufacturer | Wu's Tech Co., Ltd. | PUC Perfect Union Co.,
Ltd. | -- |
| | Proprietary name | Electrical Scooter | Foldable Mobility
Scooter | -- |
| | Model name | WT-T4QP2 | i3 | -- |
| | 510(k) No. | TBA | K191356 | -- |
| | Indication for use | The device is intended
for medical purposes
to provide mobility to
persons restricted to a
sitting position. | The device is intended
for medical purposes to
provide mobility to
persons restricted to a
sitting position. | Same |
| | Overall Dimensions
(LxWxH) | 36.2" x 16.9" x 35.8" | 39.9" x 18.4"x 38.6" | Similar |
| | Manual folding | Yes | Yes | Same |
| | Operating
environments | Indoor/ outdoor | Indoor/outdoor | Same |
| | Number of Wheels | 4 | 4 | Same |
| | Frame | Fixed / Aluminum
alloy | Fixed / Aluminum alloy | Same |
| | Front wheel size &
type | 6.49"x 1.96"x2
(PU solid tire) | 7" x 2"x 2
(PU Solid tire) | Similar |
| | Rear wheel size & type | 7.28"x 1.96"x2
(PU solid tire ) | 8" x 2"x2
(PU solid tire) | Similar |
| | Battery | One Lithium-ion
battery pack
25.2 VDC /10.35 Ah | Two Lithium-ion
batteries
25.4 DCV/ 11.6 Ah | Similar |
| | Off-board charger | Off-board charger | Same | |
| Charger type & rating | Input AC100-240V,
Output DC 29.4V, 2A | Input: AC100-240V
Output: DC 29.4 V | | |
| Battery weight | 4.4 lbs. (1.98 kg) | 3.8 lbs. (1.72 kg) | Similar | |
| Armrest | No | No | Same | |
| Motor | DC24V / 180W | DC 24V /270W | Similar | |
| Driving System | Rear wheel drive | Rear wheel drive | Same | |
| Brake System | Electromagnetic brake | Electromagnetic brake | Same | |
| Anti-tipper | Yes | Yes | Same | |
| Max Forward Speed | 4 mph /6.4 km/h | 3.7 mph /6.0 km/h | Similar | |
| Biocompatibility | ISO 10993-1:2018
ISO 10993-5:2009
ISO 10993-10:2010 | ISO 10993-1:2009
ISO 10993-5:2009
ISO 10993-10:2010 | Same | |
| Height adjustable tiller | No | Yes | Different | |
| Back upholstery | PU Foam | Fabric | Different | |
| Maximum safe
operational incline | 6 degrees | 8 degrees | Different | |
| Weight, w/ Battery | 45.8 lbs. (20.8 kg) | 59.5 lbs. (26.99 kg) | Different | |
| w/o Battery | 41.4 lbs.(18.82 kg) | 55.6 lbs. (25.24 kg) | Different | |
| Cruising Range | 9.06 miles/14.5 km | 5.67 miles /9.13 km | Different | |
| Max Loading | 250 lbs./115 kg | 300 lbs. / 137 kg | Different | |
| Turning Radius | 55.9" / 1420 mm | 59" / 1500 mm | Different | |
| Electronics controller | Dynamic DR50 | Penny & Giles S-Drive | Different | |
| Ground clearance | 1.1"/ 28 mm | 1.7"/ 43 mm | Different | |
| Curb climbing | 1.58"/ 40 mm | 2"/50 mm | Different | |
7
8
● Substantial equivalent discussion
The same or similar items will not be discussed and only the different items will be discussed.
The height of turning tiller for the subject device cannot be adjusted and it can be adjusted for the predicate device. A height-adjustable turning tiller means the user can change the height of turning tiller according to the sizes of different users, thus bring more convenience to the users. A height adjustable tiller also has a risk of loose of fixing knob, and this harm will lead to serious injury of users in some cases. Though, a fixed-height tiller has no this kind of convenience, it can keep safety well. There are no any new safety or effectiveness concerns raised by the subject device due to a fixed height tiller.
The material of back upholstery for the subject device is PU Foam and it is Fabric for the predicate device. The PU Foam material has soft feeling to users, and fabric material has some kinds of hardness feeling to users. The safety concerns for back upholstery focus on the ignition resistance testing, and the subject device passed the ISO 7176-16:2012 Wheelchairs – Part 16: Resistance to ignition of postural support devices. Thus, there are no any new safety or effectiveness concerns raised by the subject device for the different back upholstery materials used.
The Maximum safe operational incline for the subject device is 6 degrees and it is 8 degrees for the predicate device. The difference of 2 degrees incline means the predicate device can climb steeper incline than the subject device. But we have informed the users of not to operate the subject device on the incline higher than 6 degrees in the labeling. So, there are no any new safety and effectiveness concerns raised by subject device for a 6-degree maximum safe operational incline.
The Scooter weight with battery is 45.8 lbs. for subject device and it is 59.5 lbs. for predicate device. The predicate device is heavier than the subject device by 13.7 lbs. The 13.7 lbs. difference mainly comes from the larger overall dimensions of frame for predicate device. Larger scooter weight will lead to a smaller cruising range according to the principle of conservation of energy. The difference between these two scooters' weight will not raise any new safety and effectiveness concerns for the subject device.
9
The Cruising range is 9.06 miles for the subject device and it is 5.67 miles for the predicate device. The difference of cruising range just comes from different designs of the scooters, not related to safety or effectiveness concerns. Moreover, we provide the 9.06 miles cruising range of WT-T4QP2 in the relevant labeling to inform the users of this cruising range. Normally, scooter with larger cruising range leads to lower frequency of charging battery, thus bring about more convenience to the user. There are no any new safety and effectiveness concerns raised by the subject device due to the larger cruising range.
The Max loading is 250 pounds for the subject device and it is 300 pounds for the predicate device. We provide the max loading data in the WT-T4QP2 labeling to inform users of this data. The users have the duty of noticing and observing the labeling, thus, there are no any new safety and effectiveness concerns raised by the subject device due to the different max loading.
The Turning radius is 55.9 inches for subject device and it is 59 inches for the predicate device. The larger turning radius will have more limitations of turning around space to the scooter with larger radius, i.e., predicate device. So, there are no any new safety and effectiveness concerns raised by the subject device.
The Electronics controller is Dynamic DR50 for subject device and it is PG S-Drive for predicate device. The subject device which contains the electronic controller DR50 together passes the RESNA WC-2:2019 Section 14, thus safety of electronic controller is ensured, and there are no any new safety and effectiveness concerns raised by the subject device due to using different electronic controller.
The Ground clearance is 1.1 inches for subject device and it is 1.7 inches for predicate device. The users should notice this data in labeling when operate the scooter to pass the obstacle, otherwise there is damage to the chassis of scooter. If the users observe the labeling, there are no any new safety and effectiveness concerns raised by the subject device due to the smaller ground clearance.
The Curb climbing is 1.58 inches for the subject device and it is 2 inches for predicate device. The users should notice this data in labeling when operate the scooter to meet the curb, otherwise the scooter will not pass over the curb and will have impact on the scooter. If the users observe the curb labeling, there are no any new safety and effectiveness concerns raised by the subject device due to the smaller climbing curb.
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● Conclusions:
The subject device, WT-T4QP2, is as safe and effective as, and functions in a manner equivalent to the predicate device - i3 Foldable Mobility Scooter. The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus, the subject device is substantially equivalent to the predicate device.