(207 days)
Not Found
No
The device description and intended use focus on basic mobility features and do not mention any AI/ML capabilities. There is no mention of image processing, AI/ML terms, or performance metrics typically associated with AI/ML algorithms.
No.
The scooter provides transportation for disabled or elderly individuals, but it does not directly treat or diagnose a disease or condition. It is an assistive device rather than a therapeutic one.
No
The device, a mobility scooter, is intended for transportation and does not perform any diagnostic functions like detecting, monitoring, or predicting health conditions or diseases.
No
The device description clearly outlines a physical mobility scooter with hardware components like batteries, wheels, a seat, and hand controls. 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 for transportation of disabled or elderly individuals. This is a physical mobility aid, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical scooter with batteries, wheels, a seat, and controls. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or laboratory procedures.
Therefore, the C.T.M. Mobility Scooter HS-115 falls under the category of a medical device for mobility assistance, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The C.T.M. Mobility Scooter HS-115 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Product codes
INI
Device Description
The C.T.M. Mobility Scooter HS-115 is an indoor/outdoor scooter that is powered by two 12Ah lead-acid batteries, equipped with three wheels, capacity of 115 kilograms and a lightweight adjustable seat. It's a rear wheel drive scooter with theoretical driving ranges of 10 kilometer. 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 disassembled for transport and is provided with an off-board battery charger. The maximum speed is 4 m.p.h.
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)
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 sesnitization
- EN 60601-1:2006 +A11:2011 + A1:2013 + A12:2014 Part 1: General Requirements for basic safety and essential performance
- IEC 60601-1-2 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
- ISO 7176-25 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
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 Wheelchairs Part 1: Determination of static stability
- ISO 7176-2 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
- ISO 7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes
- 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
- ISO 7176-6 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- 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 7176-15 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
- ISO 7176-16 Wheelchairs Part 16: Resistance to ignition of postural support devices
- ISO 7176-22 Wheelchairs Part 22: Set-up procedures
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
December 14, 2018
Chien Ti Enterprise Co., Ltd. Vivian Lo Sales Manager No. 13, Lane 227, Fu Ying Rd New Taipei City, Hsin Chuang District, CN 24258 Taiwan
Re: K181344
Trade/Device Name: C.T.M Mobility Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: September 14, 2018 Received: September 17, 2018
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.
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181344
Device Name C.T.M. Mobility Scooter
Indications for Use (Describe)
The C.T.M. Mobility Scooter HS-115 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
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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Chuang District., New Tai 2-2904-1170 · 2903 http://www.chienti.com. ales@chienti.com tw
510(k) Summary
Company Name: Company Address:
CHIEN TI ENTERPRISE CO., LTD. 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: December 13, 2018
Device Name:
Contact Person:
Telephone:
Fax:
| Trade Name: | C.T.M. Mobility Scooter, HS-115 |
|---|---|
| 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-115 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Device Description
The C.T.M. Mobility Scooter HS-115 is an indoor/outdoor scooter that is powered by two 12Ah lead-acid batteries, equipped with three wheels, capacity of 115 kilograms and a lightweight adjustable seat. It's a rear wheel drive scooter with theoretical driving ranges of 10 kilometer. 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 disassembled for transport and is provided with an off-board battery charger. The maximum speed is 4 m.p.h.
4
Substantial Equivalence Comparison
The C.T.M. Mobility Scooter, HS-115 and the Freerider Corporation mobility scooter Luggie Super (K151944) have same intended use and classification name/ product code.
The C.T.M. Mobility Scooter. HS-115 and the Freerider Corporation mobility scooter Luggie Super similar design features. Regarding the HS-115, the dimensions is bigger and heavier, but not significantly. Both scooters have same 3 wheels, rear-wheel drive technology, Electro-Mechanical brakes, Dismantle for transport. 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 a single motor and two batteries. 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-115 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-115 has been also tested to applicable ANSI/RESNA, ISO, IEC standards which are included in this submission.
| Category | C.T.M. Mobility Scooter,
HS-115
New device | Freerider Corporation Scooter
Luggie Super
K151944 | Result of
Comparison |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Indications for
Use (IFU)
statement | The C.T.M. Mobility Scooter
HS-115 in an indoor/outdoor
scooter that provides
transportation for a disabled or
elderly person. | 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 |
5
| Category | C.T.M. Mobility Scooter,
HS-115
New device | Freerider Corporation
Scooter #Luggie Super
K151944 | Result of
Comparasion |
|---------------------|--------------------------------------------------|-----------------------------------------------------------|--------------------------|
| Classification name | 890.3800 Motorized
3-wheeled vehicle | 890.3800 Motorized
3-wheeled vehicle | Same |
| Product Code | INI | INI | Same |
6
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.
-
Part 5: Test for in vitro cytotoxicity ● ISO 10993-5 ● ISO 10993-10 Part 10: Tests for irritation and skin sesnitization ● EN 60601-Part 1: General Requirements for basic safety and essential performance 1:2006 +A11:2011 + A1:2013 + A12:2014 60601-1-2 Part 1-2: General requirements for basic safety and essential performance -● IEC Collateral standard: Electromagnetic compatibility - Requirements and tests 7176-14 Wheelchairs - Part 14: Power and control systems for electrically powered ● ISO 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 ● ISO 7176-25 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
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
-
ISO Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs 7176-2
-
Wheelchairs Part 3: Determination of effectiveness of brakes ● ISO 7176-3
7176-4 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for ● ISO
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
- ISO Wheelchairs - Part 7: Measurement of seating and wheel dimensions 7176-7
7
● 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 7176-15 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
- ISO 7176-16 Wheelchairs Part 16: Resistance to ignition of postural support devices
- ISO 7176-22 Wheelchairs Part 22: Set-up procedures
8
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-115 has the same intended 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-115 is substantially equivalent to the predicate devices with respect to its intended use, technological characteristics and performance characteristics.