← Product Code [ITI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI) · K100527 # HOVEROUND TEKNIQUE, MODEL HD-6 (K100527) _Hoveround Corp. · ITI · Mar 26, 2010 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K100527 ## Device Facts - **Applicant:** Hoveround Corp. - **Product Code:** [ITI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI.md) - **Decision Date:** Mar 26, 2010 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 890.3860 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## Indications for Use The intended use is to provide mobility to persons limited to a seated position. ## Device Story Hoveround Teknique HD-6 is a powered wheelchair designed to provide mobility for individuals restricted to a seated position. Device operates via user-controlled joystick interface, translating electrical signals into motor-driven movement. Used in home and community settings by patients with mobility impairments. Provides independent navigation and positioning. No complex AI/ML algorithms; standard power mobility control system. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Powered wheelchair; electric motor drive; joystick control interface; intended for indoor/outdoor mobility; standard power mobility construction. ## Regulatory Identification A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. 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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Hoveround Corporation % Mr. Tony Digiovanni Director of Engineering 2151 Whitfield Industrial Way Sarasota, Florida 34243 ## MAR 2 3 2010 Re: K100527 Trade/Device Name: Hoveround Teknique HD- 6 Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: February 17, 2010 Received: February 24, 2010 Dear Mr. Digiovanni: 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 davice, 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 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 {1}------------------------------------------------ Page 2 - Mr. Tony Digiovanni 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/AboutFDA/CentersOffices/CDRH/CDRHOffices/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/Resourcesfor You/Industry/default.html Sincerely yours, y yours, For Peter Del Dil Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Hoveround Teknique HD-6 Power Wheelchair Device Name: Indications for Use: The intended use is to provide mobility to persons limited to a seated position. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) FOR M. MELKERSON (Division S Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K100527 Page 1 of X --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K100527](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K100527) **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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