(109 days)
Not Found
No
The device description and intended use describe a standard mobility scooter with no mention of AI or ML features. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a mobility scooter for transportation, not for treating or diagnosing a medical condition.
No
The device description and intended use clearly state that the C.T.M. Mobility Scooter HS-528 is for transportation, not for diagnosing any medical condition.
No
The device description clearly outlines a physical, battery-operated scooter with wheels, a seat, and a steering column, indicating it is a hardware device.
No, the C.T.M. Mobility Scooter HS-528 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples such as blood, urine, or tissue, taken from the human body to detect diseases, conditions, or infections.
- Device Function: The description clearly states the scooter's purpose is to provide transportation for disabled or elderly individuals. It is a mobility aid, not a device that performs tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any features related to sample collection, analysis, or diagnostic testing.
Therefore, based on the provided information, the C.T.M. Mobility Scooter HS-528 falls under the category of a mobility device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The C.T.M. Mobility Scooter HS-528 is 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-528 is an indoor/outdoor scooter that is battery operated. It has a base with four wheels, a padded seat with adjustable armrests, and a steering column allowing the rider to control the scooter. The scooter folds into a compact unit for ease of transport and is provided with an off-board 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 Scooters, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the submission. Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
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
C.T.M. Mobility Scooter HS-528 510(k) Notification
JUL - 6 2009
10090735
510(k) SUMMARY
| Submitter's name: | C.T.M. Homecare Product, Inc.
6191 Schaefer Ave., Suite B, Chino, CA 91710 |
| ------------------- | ------------------------------------------------------------------------------- |
|---|
Contact name and address:
Linda J. Bovard, Bovard Consulting, LLC 29611 Simmons Road, Eugene, OR 97405 . (541) 345-5431
3/16/09 Date summary prepared:
Device name:
Proprietary name: Common or usual name: Classification name:
C.T.M. Mobility Scooter HS-528 or Leo Electric scooter Motorized three-wheeled vehicle (890.3800). Motorized 3-wheeled vehicle (89 INI).
Legally marketed device for substantial equivalence comparison:
The predicate device is the Victory, 4 Wheel Scooter, Model #SC1740 submitted by Pride Mobility Products Corp. and cleared for marketing under 510(k) *K071949.
Description of the device:
The C.T.M. Mobility Scooter HS-528 is an indoor/outdoor scooter that is battery o The O.Tht has a base with four wheels, a padded seat with adjustable armrests, and operated. It has a base were mg column allowing the rider to control the scooter. nance outs of a lots of transport and is provided with an off-board battery charger.
Intended use of device:
The C.T.M. Mobility Scooter HS-528 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Technological characteristics:
The device features of the C.T.M. Mobility Scooter HS-528 and the Victory Scooter are r no do rill reacur are battery operated, have one motor, and have automatic braking very smilling. Do are battery chargers are provided with both scooters. Both scooters can Systembled for transport. The target population is identical and the use parameters are similar.
Testing conducted:
, contactor.
Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the submission.
Performance testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
C.T.M. Homecare Product, Inc. % Bovard Consulting LLC. Ms. Linda J. Bovard 29611 Simmons Road Eugene, Oregon 97405
JUL - 6 2009
Re: K090735
Trade/Device Name: C.T.M. Mobility Scooter HS-528 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: May 8, 2009 Received: May 11, 2009
Dear Ms. Bovard:
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. 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 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); 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.
2
Page 2 - Ms. Linda J. Bovard
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: C.T.M. Mobility Scooter HS-528
Indications for Use;
The C.T.M. Mobility Scooter HS-528 is an indoor/outdoor scooter that provides The C. F.m. Intonesial sabled or elderly person.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
AND THE BELOW - NEEDED) NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090735