(201 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
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.
This FDA 510(k) summary describes a new medical device, the Electrical Scooter, model WT-T4QP2, and compares it to a predicate device, the i3 Foldable Mobility Scooter (K191356), to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Key Takeaway: This 510(k) is for a medical mobility scooter. The "acceptance criteria" discussed are primarily related to safety and performance standards for wheelchairs and motorized scooters, with a strong emphasis on demonstrating equivalence to a previously cleared predicate device. There is no AI component in this device, so questions related to AI performance, such as MRMC studies, human reader improvement with AI, or standalone AI performance, are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not present a formal "acceptance criteria" table in the way one might expect for a diagnostic device with specific performance metrics (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly defined by compliance with a set of international and national performance standards for wheelchairs and motorized scooters, and by demonstrating substantial equivalence to the predicate device across various specifications.
The "reported device performance" is primarily the device's adherence to these standards and a comparison of its specifications with the predicate.
| Acceptance Criteria (Standards and Equivalence Points) | Reported Device Performance (as per submission) |
|---|---|
| Performance Standards: | Complied By Device (WT-T4QP2): |
| - ISO 7176-1:2014 (Static stability) | Performance testing was conducted to these standards. |
| - ISO 7176-2:2017 (Dynamic stability of electric WCs) | Performance testing was conducted to these standards. |
| - ISO 7176-3:2012 (Effectiveness of brakes) | Performance testing was conducted to these standards. |
| - ISO 7176-4:2008 (Energy consumption/range) | Performance testing was conducted to these standards. |
| - ISO 7176-5:2008 (Overall dimensions, mass, maneuver) | Performance testing was conducted to these standards. |
| - ISO 7176-6:2001 (Max speed, accel, decel) | Performance testing was conducted to these standards. |
| - ISO 7176-7:1998 (Seating dimensions) | Performance testing was conducted to these standards. |
| - ISO 7176-8:1998 (Static, impact, fatigue strength) | Performance testing was conducted to these standards. |
| - ISO 7176-9:2009 (Climatic tests for electric WCs) | Performance testing was conducted to these standards. |
| - ISO 7176-10:2008 (Obstacle-climbing ability) | Performance testing was conducted to these standards. |
| - ISO 7176-16:2012 (Resistance to ignition, postural support) | Pass (for back upholstery) |
| - RESNA WC-2:2019 Section 14 (Power & control systems) | Pass (for electronic controller) |
| - RESNA WC-2:2019 Section 21 (EMC) | Performance testing was conducted to this standard. |
| Biocompatibility Standards: | Complied By Device (WT-T4QP2) for patient-contacting parts (Handle bar grip, Seat, Speed lever): Cytotoxicity, Sensitization and Irritation tests conducted for all, all Pass. Standards cited: ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010. |
| Substantial Equivalence (General): | Same or Similar to predicate in: Indications for Use, Manual folding, Operating environments, Number of Wheels, Frame, Off-board charger, Armrest, Driving System, Brake System, Anti-tipper, Biocompatibility standards. Similar or Different but not raising new S&E concerns in: Overall Dimensions, Wheel sizes, Battery, Charger type & rating, Battery weight, Motor, Max Forward Speed, Height adjustable tiller (difference mitigated by safety claim), Back upholstery (difference mitigated by ISO 7176-16 pass), Maximum safe operational incline (difference mitigated by labeling), Weight w/ Battery and w/o Battery (difference mitigated by no S&E concerns), Cruising Range (difference mitigated by labeling), Max Loading (difference mitigated by labeling), Turning Radius (advantage to subject device), Electronics controller (difference mitigated by RESNA WC-2:2019 Section 14 pass), Ground clearance (difference mitigated by labeling), Curb climbing (difference mitigated by labeling). |
Studies and Information Provided:
Since this is a filing for a non-AI medical device (an electric scooter), the typical questions about AI performance metrics (sensitivity, specificity, AUROC, MRMC, etc.) are not applicable. The "study" here refers to non-clinical performance and safety testing.
2. Sample size used for the test set and the data provenance:
- The document describes performance testing against various ISO and RESNA standards. This testing is typically conducted on a limited number of manufactured units, rather than a "test set" from a patient population. The exact sample size (number of scooters tested) is not specified, but it would align with standard engineering and regulatory testing practices for device robustness and functionality.
- Data provenance: This would be prospective testing conducted by the manufacturer or accredited labs on the actual device units. The country of origin for the data is implicitly Taiwan, where the manufacturer is located, or potentially international testing labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not directly applicable. "Ground truth" for an electric scooter is defined by whether it successfully meets the specified performance parameters of the ISO and RESNA standards (e.g., "does it stop within X distance?" "does it maintain stability at Y incline?"). This is determined through objective measurements and test protocols, not expert consensus in a clinical sense. The "experts" would be the engineers and technicians conducting the tests and interpreting the results against the standard's requirements.
4. Adjudication method for the test set:
- Not applicable in the context of objective engineering performance testing. Compliance is determined by direct measurement against quantitative thresholds defined in the standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this device does not involve AI. Therefore, an MRMC study or any assessment of AI assistance is not relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this device does not involve AI. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used:
- For the performance tests: Objective measurements against defined thresholds in international and national engineering standards (ISO 7176 series, RESNA WC-2 series).
- For biocompatibility: Laboratory test results (Cytotoxicity, Sensitization, Irritation) against biological endpoints defined by ISO 10993 standards.
8. The sample size for the training set:
- Not applicable. This is a hardware device without an AI component that would require a "training set" of data.
9. How the ground truth for the training set was established:
- Not applicable. No training set exists for this device.
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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.
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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
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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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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
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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, ●
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- 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-contactingParts | Materials | Rational accordingtoWu's Tech expertise | Tests conducted | Verdict |
|---|---|---|---|---|
| Handle bar grip | DIOSHYTPV | No customerclaim withadverseconditions formore than 300thousand units inthe market. | Cytotoxicity,Sensitizationand Irritationtests | Pass |
| Seat | PU | No customerclaim withadverseconditions formore than 300thousand units inthe market. | Cytotoxicity,Sensitizationand Irritationtests | Pass |
| Speed lever | PVC(NAN YAFR-PA66) | No customerclaim withadverseconditions formore than 250thousand units inthe market. | Cytotoxicity,Sensitizationand Irritationtests | Pass |
Biocompatibility evaluation per ISO 10993-1:2018 ●
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Comparison table ●
| DevicesSpecifications | Subject device | Predicate device | Comparisonverdict | |
|---|---|---|---|---|
| Manufacturer | Wu's Tech Co., Ltd. | PUC Perfect Union Co.,Ltd. | -- | |
| Proprietary name | Electrical Scooter | Foldable MobilityScooter | -- | |
| Model name | WT-T4QP2 | i3 | -- | |
| 510(k) No. | TBA | K191356 | -- | |
| Indication for use | The device is intendedfor medical purposesto provide mobility topersons restricted to asitting position. | The device is intendedfor medical purposes toprovide mobility topersons restricted to asitting 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 | |
| Operatingenvironments | Indoor/ outdoor | Indoor/outdoor | Same | |
| Number of Wheels | 4 | 4 | Same | |
| Frame | Fixed / Aluminumalloy | 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-ionbattery pack25.2 VDC /10.35 Ah | Two Lithium-ionbatteries25.4 DCV/ 11.6 Ah | Similar | |
| Off-board charger | Off-board charger | Same | ||
| Charger type & rating | Input AC100-240V,Output DC 29.4V, 2A | Input: AC100-240VOutput: 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 10993-1:2018ISO 10993-5:2009ISO 10993-10:2010 | ISO 10993-1:2009ISO 10993-5:2009ISO 10993-10:2010 | Same | |
| Height adjustable tiller | No | Yes | Different | |
| Back upholstery | PU Foam | Fabric | Different | |
| Maximum safeoperational 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 |
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● 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.
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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.
§ 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).