(14 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard mobility scooter and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device provides transportation for disabled or elderly persons, but it does not treat or prevent a disease or condition. Its function is primarily assistive.
No
Explanation: The device description and intended use clearly state that this is a mobility scooter for transportation, not for diagnosing medical conditions. It does not mention any function related to identifying, monitoring, or predicting diseases or health states.
No
The device description clearly states it is an electric scooter with physical components like wheels, a seat, armrests, and a battery, indicating it is a hardware device, not software-only.
Based on the provided information, the C.T.M. Mobility Scooter HS-235 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for providing transportation for a disabled or elderly person. This is a physical mobility aid, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical scooter with wheels, a seat, controls, and a battery. This aligns with a transportation device, not a laboratory or testing instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, assays, or any other components typically associated with IVD devices.
Therefore, the C.T.M. Mobility Scooter HS-235 falls under the category of a mobility aid, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The C.T.M. Mobility Scooter HS-235 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
The C.T.M. Mobility Scooter HS-235 is an indoor/outdoor electric scooter that is battery operated. It has a base with three wheels with a lightweight seat, armrests, and a front basket. 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 onboard battery charger.
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)
Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the subject 510(k) submission.
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
Clinical performance evaluations are not necessary to demonstrate substantial equivalence to the predicate device.
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
OCT - 6 2003
510(k) SUMMARY
Submitter's Name: C.T.M. Homecare Product, Inc. 1663 Iowa Ave. Riverside, CA 92507 909-788-8168
Date summary prepared:
September 10, 2003
Device name:
Proprietary name: Common or usual name: Classification name:
C.T.M. Mobility Scooter HS-235 Electric scooter. Motorized three-wheeled vehicle, Class II, 21 CFR 890.3800.
Legally marketed device for substantial equivalence comparison:
C.T.M. Mobility Scooter HS-120 submitted by C.T.M. Homecare Product, Inc. and cleared for marketing under 510(k) *K031272.
Description of the device:
The C.T.M. Mobility Scooter HS-235 is an indoor/outdoor electric scooter that is battery operated. It has a base with three wheels with a lightweight seat, armrests, and a front basket. 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 onboard battery charger.
Intended use of device:
The device is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Technological characteristics:
The device features and use parameters of the HS-235 and the HS-120 are very similar. They vary only in parameters like dimensions and the size of the motor. Both are electric scooters that are battery operated and have automatic braking systems. Batteries and battery chargers are provided with each scooter.
Testing conducted:
Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the subject 510(k) submission.
Performance testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
1
C.T.M. Mobility Scooter HS-235 510(k) Notification Page 13
V. Clinical Performance Evaluations
Clinical performance evaluations are not necessary to demonstrate substantial equivalence to the predicate device.
VL. Conclusion
In summary, based on a comparison of regulatory issues, device features, and use parameters, the C.T.M. Mobility Scooter HS-235 is substantially equivalent to the C.T.M. Mobility Scooter HS-120.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure with three wavy lines extending from the head, resembling a bird in flight.
Public Health Service
OCT - 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
C.T.M. Homecare Product, Inc. c/o Mr. Robert S. McQuate President R.S. McQuate & Associates, Inc. 3636 E. Columbine Drive Phoenix, AZ 85032
Re: K032918
Trade/Device Name: C.T.M. Mobility Scooter HS-235 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI September 12, 2003 Dated: Received: September 22, 2003
Dear Mr. McQuate:
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 contrôls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Mr. Robert S. McQuate
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): _
Device name: C.T.M. Mobility Scooter HS-235
Indications for Use:
The C.T.M. Mobility Scooter HS-235 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
(Please do not write below this line) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation for
:10(k) Number --
Mark A. Milburn
(Division Sign-Off) Division of General, R Corative and Neurological Devilus 032918
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use ______________