(54 days)
The C.T.M. Mobility Scooter HS-628 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
The C.T.M. Mobility Scooter HS-628 is an indoor/outdoor scooter that is battery operated, has three wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column allowing the rider to control the scooter. It is provided with an off-board battery charger.
This document is a 510(k) premarket notification for a C.T.M. Mobility Scooter HS-628. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI-driven medical device.
The document states:
- "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
- The device is a "C.T.M. Mobility Scooter HS-628 or Orion Electric scooter Motorized three-wheeled vehicle."
- Its intended use is to "provide transportation for a disabled or elderly person."
- The 510(k) notification focuses on demonstrating "substantial equivalence" to a predicate device (C.T.M. Mobility Scooter HS-890) based on similar technological characteristics (e.g., both are battery operated, have two wheels, one motor, automatic braking systems).
- It mentions "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Wheelchairs and Scooters, and Motorized Three Wheeled Vehicles" were conducted, but the specific results or acceptance criteria are not detailed, nor are they framed as performance metrics for an AI system.
Therefore, I cannot provide the requested information for an AI-driven medical device, as this document pertains to a mobility scooter and explicitly states that comparative performance testing and clinical evaluations were not submitted. The questions you've asked are relevant for AI/ML-based medical devices or diagnostics, which this product is not.
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C.T.M. Mobility Scooter HS-628 510(k) Notification
JUL - 6 2009
510(k) SUMMARY
| Submitter's name: | C.T.M. Homecare Product, Inc. |
|---|---|
| 6191 Schaefer Ave., Suite B, Chino, CA 91710 |
Linda J. Bovard, Bovard Consulting, LLC Contact name and address: 29611 Simmons Road, Eugene, OR 97405 (541) 345-5431
2/11/09 Date summary prepared:
Device name:
Proprietary name: Common or usual name: Classification name:
C.T.M. Mobility Scooter HS-628 or Orion 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 C.T.M. Mobility Scooter HS-890 submitted by C.T.M. Homecare Product, Inc. and cleared for marketing under 510(k) *K030387.
Description of the device:
The C.T.M. Mobility Scooter HS-628 is an indoor/outdoor scooter that is battery The C.L.M. Hooney Doubler wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column allowing the rider to control the scotter. It is provided with an off-board battery charger.
Intended use of device:
The C.T.M. Mobility Scooter HS-628 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-628 and the HS-890 are very I he uevice features of the or med, have one motor, and have automatic braking systems. similar. Dour are battery operated, sided with both scooters. The target population is identical and the use parameters are similar.
Testing conducted:
Tests listed in the Guidance Document for the Preparation of Premarket Notification I costs Insted in the Gatance Boomical and Scooters, and Motorized Three Wheeled [ 710(k)] Applications for noomarted and the results included in the submission.
Performance testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
C.T.M. Homecare Product, Inc. % Bovard Consulting LLC Ms. Linda Bovard 29611 Simmons Road Eugene, Oregon 97405
JUL - 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K091418
Trade/Device Name: C.T.M. Mobility Scooter HS-628 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: May 11, 2009 Received: May 13, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Ms. Linda 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
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C.T.M. Mobility Scooter HS-628 510(k) Notification
Indications for Use
510(k) Number (if known):
Device Name: C.T.M. Mobility Scooter HS-628
Indications for Use:
The C.T.M. Mobility Scooter HS-628 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K0914/8
§ 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).