(60 days)
Not Found
No
The device description and intended use focus on basic mobility functions controlled by the user. There is no mention of AI, ML, or any features that would suggest autonomous decision-making or learning capabilities.
No.
The primary purpose of the device is transportation, not treatment or diagnosis of a disease or condition. While it aids disabled or elderly individuals, it does not directly manage or treat a medical condition.
No
This device is a mobility scooter designed for transportation, not for diagnosing medical conditions or diseases. Its purpose is to assist disabled or elderly individuals with mobility.
No
The device description clearly outlines a physical mobility scooter with hardware components (battery, wheels, motor, hand controls, charger). It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The C.T.M. Mobility Scooter HS-268 is a mobility aid designed to provide transportation for individuals with disabilities or the elderly. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it provides "transportation for a disabled or elderly person."
- Device Description: The description focuses on the physical characteristics and functionality of a scooter (battery, wheels, speed, controls).
- Lack of Relevant Information: The document lacks any mention of biological samples, testing, analysis, or diagnostic purposes.
Therefore, based on the provided information, the C.T.M. Mobility Scooter HS-268 is a mobility device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person in age of 16 up to 85 year old.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that is powered by 25.2Vdc, 11000mAh, 277.2Wh (min) and 25.2Vdc, 11600mAh, 292.32Wh (typ) Lithium battery, equipped with four wheels, capacity of 253.5 lbs and a lightweight seat. It's a rear wheel drive scooter with theoretical driving ranges of 9.3 miles. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be folded/unfolded and is provided with an off-board battery charger. The maximum speed is 5 mph.
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
16 up to 85 year old
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)
Non-clinical tests were performed. The safety tests, such as biocompatibility and electrical safety have been performed and meet the requirement of following FDA Recognized Consensus Standards: ISO 10993-5, ISO 10993-10, EN 60601-1:2006 +A11:2011 + A1:2013 + A12:2014, IEC 60601-1-2, ISO 7176-14, ISO 7176-21, IEC 62133.
Regarding the performance, the bench tests were performed in accordance with following FDA Recognized Consensus Standards. All tests passed the requirement to demonstration that new device is as substantial equivalent as the predicate device: ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-6, ISO 7176-7, ISO 7176-8, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-15, ISO 7176-16, ISO 7176-22.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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.
Chien Ti Enterprise Co., Ltd. Vivian Lo Sales Director No. 13, Lane 227, Fu Ying Rd New Taipei City, Hsin Chuang District, 24258 Taiwan
Re: K192885
Trade/Device Name: C.T.M. Mobility Scooter HS-268 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: October 9, 2019 Received: October 10, 2019
Dear Vivian Lo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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).
Sincerely,
Acting Assistant Director, Acute Injuries 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
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Indications for Use
510(k) Number (if known) K192885
Device Name C.T.M. Mobility Scooter HS-268
Indications for Use (Describe)
The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person in age of 16 up to 85 year old.
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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Image /page/3/Picture/0 description: The image is a logo for C.T.M. The logo is an oval shape with a gray border. Inside the oval, the letters "C.T.M." are written in red, with blue swooshes above and below the letters.
EN TI ENTERPRISE CO., LT
ane 227, Fu Ying Rd., Hsin Chuang District., New Taipei City, Taiwan 886-2-2904-1170 · 2903-88 http://www.chienti.com.tv ales@chienti.com tw
510(k) Summary
CHIEN TI ENTERPRISE CO., LTD.
Company Name: Company Address:
No. 13, Lane 227, Fu Ying Rd New Taipei City, Hsin Chuang District, 24258, TAIWAN (CHINA) +886-2-29032987 +886-2-29038807 Ms. Vivian Lo Summary Preparation Date: October 9, 2019
Device Name:
Contact Person:
Telephone:
Fax:
Trade Name: C.T.M. Mobility Scooter, HS-268 Classification Name: Motorized three-wheeled vehicle Regulation Number: 890.3800 Product Code: INI Device Class: Class 2 Panel: Physical Medicine
PREDICATE DEVICE:
K151944, Freerider Corporation Luggie Super
Indications for Use (IFU) statement:
The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person in age of 16 up to 85 year old.
Device Description
The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that is powered by 25.2Vdc, 11000mAh, 277.2Wh (min) and 25.2Vdc, 11600mAh, 292.32Wh (typ) Lithium battery, equipped with four wheels, capacity of 253.5 lbs and a lightweight seat. It's a rear wheel drive scooter with theoretical driving ranges of 9.3 miles. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be folded/unfolded and is provided with an off-board battery charger. The maximum speed is 5 mph.
4
Substantial Equivalence Comparison
The C.T.M. Mobility Scooter, HS-268 and the Freerider Corporation mobility scooter # Luggie Super (K151944) have similar indications for use and same classification name/ product code.
The C.T.M. Mobility Scooter, HS-268 and the Freerider Corporation mobility scooter #Luggie Super have similar design features. Regarding the HS-268, the dimension is bigger and heavier, but not significantly. Both scooters have same 4 wheels, rear-wheel drive technology, electro-mechanical brakes. The control systems are used for exact same model, Dynamic Rhino 50 controllers (DR50). The features on the tiller and controller are same. Each scooter has s single motor and battery. The differences are motor size, capacity and output of battery. All the differences don't affect the safety and performance after verified by safety and performance test.
The HS-268 with its built in modern technologies for improvements in effectiveness and safety, in many comparable criterions, considered fairly similar to its predicate device: Luggie Super. Furthermore, the HS-268 has been also tested to applicable ANSVRESNA. ISO. IEC standards which are included in this submission.
| Category | C.T.M. Mobility Scooter,
HS-268
New device | Freerider Corporation
Luggie Super
K151944 | Result of
Comparison |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Indications for
Use | The C.T.M. Mobility Scooter
HS-268 is an indoor/outdoor
scooter that provides
transportation for a disabled
or elderly person in age of 16
up to 85 year old. | The FR-L05 (Luggie Super)
provides transportation for
an elderly or disabled
person. It can be used in a
variety of indoor and
outdoor settings. | Similar |
| Prescription Use
or
Over-the-counter
Use | Over-the-counter Use | Over-the-counter Use | Same |
| The generic
name of the
device | Electric scooter | Electric scooter | Same |
| Classification
name | 890.3800 Motorized
3-wheeled vehicle | 890.3800 Motorized
3-wheeled vehicle | Same |
| Product Code | INI | INI | Same |
5
Non-clinical tests
The safety tests, such as biocompatibility and electrical safety have been performed and meet the requirement of following FDA Recognized Consensus Standards.
| ● ISO | 10993-5 | Part 5: Test for in vitro cytotoxicity |
|---|---|---|
| ● ISO | 10993-10 | Part 10: Tests for irritation and skin sensitization |
| ● EN | 60601-1:2006 | |
| +A11:2011 + | ||
| A1:2013 + | ||
| A12:2014 | Part 1: General Requirements for basic safety and essential performance | |
| ● IEC | 60601-1-2 | Part 1-2: General requirements for basic safety and essential performance – |
| Collateral standard: Electromagnetic compatibility – Requirements and tests | ||
| ● ISO | 7176-14 | Wheelchairs - Part 14: Power and control systems for electrically powered |
| wheelchairs and scooters - Requirements and test methods | ||
| ● ISO | 7176-21 | Wheelchairs - Part 21: Requirements and test methods for electromagnetic |
| compatibility of electrically powered wheelchairs and scooters, and battery | ||
| chargers | ||
| ● IEC | 62133 | Secondary cells and batteries containing alkaline or other non-acid electrolytes |
| Safety requirements for portable sealed secondary lithium cells, and for batteries | ||
| made from them, for use in portable applications - Part 2: Lithium systems |
Regarding the performance, the bench tests were performed in accordance with following FDA Recognized Consensus Standards. All tests passed the requirement to demonstration that new device is as substantial equivalent as the predicate device.
- Wheelchairs Part 1: Determination of static stability ● ISO 7176-1
- Wheelchairs Part 2: Determination of dynamic stability of electric wheelchairs ● ISO 7176-2
- Wheelchairs Part 3: Determination of effectiveness of brakes 7176-3 ● ISO
● ISO 7176-4 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- · ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and manoeuvring space
- Wheelchairs Part 6: Determination of maximum speed, acceleration and • ISO 7176-6
deceleration of electric wheelchairs
6
- ISO 7176-7 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
- ISO 7176-8 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
- ISO 7176-9 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- ISO 7176-10 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically
powered wheelchairs
- . ISO 7176-11: Wheelchairs Part 11: Test Dummies
- . ISO 7176-13: Wheelchairs Part 13: Determination of coefficient of friction of Test Surfaces
- ISO 7176-15 Wheelchairs - Part 15: Requirements for information disclosure, documentation and
labeling
- ISO 7176-16 Wheelchairs - Part 16: Resistance to ignition of postural support devices
- 7176-22 Wheelchairs Part 22: Set-up procedures ● ISO
Clinical study
This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply.
Conclusions:
C.T.M. mobility scooter, HS-268 has similar indications for use and similar technological characteristics as the above predicate devices. Moreover, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any different questions of safety or effectiveness. Thus, C.T.M. mobility scooter. HS-268 is substantially equivalent to the predicate devices with respect to its indications for use, technological characteristics and performance characteristics.