← Product Code [INI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI) · K110395 # C.T.M. MOBILITY SCOOTER - MODEL HS 118 (K110395) _C.T.M. Homecare Product, Inc. · INI · Apr 22, 2011 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K110395 ## Device Facts - **Applicant:** C.T.M. Homecare Product, Inc. - **Product Code:** [INI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI.md) - **Decision Date:** Apr 22, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.3800 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine ## Indications for Use The C.T.M. Mobility Scooter HS-118 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person. ## Device Story Battery-operated indoor/outdoor mobility scooter; provides transportation for disabled or elderly individuals. Rider operates device via hand controls on steering column. Features adjustable seat; four-wheel base; disassembles for transport. Includes off-board battery charger. Uses STAR 70-Z controller. Enhances mobility and independence for users. ## Clinical Evidence No clinical data submitted. Substantial equivalence supported by bench testing conducted in accordance with the FDA Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles (July 1995). ## Technological Characteristics Battery-operated motorized vehicle; four-wheel configuration; adjustable seat. Features automatic braking system. Utilizes STAR 70-Z controller. Provided with off-board battery charger. Designed for indoor/outdoor use; disassembles for transport. ## Regulatory 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. ## Predicate Devices - Go-Go Ultra X (Model No. SC44X 4-wheel) ([K063389](/device/K063389.md)) - VCS S3T ([K051131](/device/K051131.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ APR 2 2 2011 ## 510(k) SUMMARY Submitter's name: C.T.M. Homecare Product, Inc. 6191 Schaefer Ave Suite B Chino, CA 91710 Contact name and address: Sheila Ramerman RAC SJR Associates 927 Throne Drive Eugene, OR 97402 PH: (541) 683-3017 Email: sramerman@aol.com Date Summary prepared: February 8, 2011 Device Names: Proprietary name: Common or usual name: Electric scooter Classification name: C.T.M. Mobility Scooter HS-118 Motorized three-wheeled vehicle (890.3800) Motorized 3-wheeled vehicle (89 INI) Legally marketed device for substantial equivalence comparison: The predicate devices for this submission are: - Go-Go Ultra X (Model No. SC44X 4-wheel), manufactured and . distributed by Pride Mobility Products Corp. and cleared under 510(k) #K063389, and - VCS S3T, distributed by Vehicles Technology Co., Ltd and cleared under K051131. Description of the Device: The C.T.M. Mobility Scooter HS-118 is an indoor/outdoor Mobility Scooter that is battery operated. It has a base with four wheels and a lightweight adjustable seat. 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. Intended Use of Device: The C.T.M. Mobility Scooter HS-118 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-118 and the Go-Go Ultra are very similar. Both are battery operated, have one motor, and have automatic braking systems. Off-board battery chargers are provided with both scooters. Both scooters can be disassembled for transport. The target population is identical and the use parameters are similar. .... 001 {1}------------------------------------------------ The HS-118 and the VCS S3T use the same controller, the STAR 70-Z controller. Bench Testing: 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). Substantial Equivalence: The HS-118 and the predicate devices have the same regulatory classification and the same intended use. The HS-118 and the Go Go Ultra have similar the bannelines in the racteristics. The HS-118 and the VCS S3T use the same controller. Non-clinical testing and specification comparison demonstrate that any differences in specifications or technology do not raise new questions of safety or effectiveness. The HS-118 is substantially equivalent to the predicate devices. 0018 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 C.T.M. Homecare Product, Inc. % SJR Associates Ms. Sheila Ramerman 927 Throne Drive Eugene, Oregon 97402 APR 2 2 2011 Re: K110395 Trade/Device Name: C.T.M. Mobility Scooter HS-118 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: February 10, 2011 Received: February 11, 2011 Dear Ms. Ramerman: 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 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 {3}------------------------------------------------ Page 2 - Ms. Sheila Ramerman 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 (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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutlFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, \$\overline{H}\$ B. re h Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ---- C.T.M. Mobility Scooter HS-118 510(k) Notification ## Indications for Use 510(k) Number (if known): Device Name: C.T.M. Mobility Scooter HS-118 Indications for Use: The C.T.M. Mobility Scooter HS-118 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person. Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ![image.png](https://i.imgur.com/9499999.png) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K110395 : ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K110395](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K110395) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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