HIROLLER ELEVATING WHEELCHAIR

K102837 · Max Mobility, LLC · IPL · Dec 23, 2010 · Physical Medicine

Device Facts

• Record ID: K102837
• Device Name: HIROLLER ELEVATING WHEELCHAIR
• Applicant: Max Mobility, LLC
• Product Code: IPL · Physical Medicine
• Decision Date: Dec 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3900
• Device Class: Class 2

Intended Use

The HiRoller Elevating Wheelchair is a product that allows wheelchair users to raise and lower their seat height while seated in the wheelchair.

Device Story

HiRoller Elevating Wheelchair is a manual wheelchair; enables users to adjust seat height while seated. Operated by the user; provides vertical elevation to improve reach and accessibility. Intended for daily mobility and functional independence in home or community settings. Benefits include increased reach, improved social interaction, and enhanced accessibility to environments designed for standing individuals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual wheelchair with mechanical seat elevation mechanism. Form factor: standard manual wheelchair frame with integrated vertical lift system. No electronic components, software, or external energy sources.

Indications for Use

Indicated for individuals requiring a manual wheelchair for mobility, including those with spinal cord injuries, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, and spina bifida.

Regulatory Classification

Identification

A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Max Mobility, LLC % Mr. William Richter CEO 5425 Mount View Parkway Antioch, Tennessee 37013

Re: K102837

Trade/Device Name: HiRoller Elevating Wheelchair Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: Class II Product Code: IPL Dated: October 25, 2010 Received: October 29, 2010

DEC 2 3 2010

Dear Mr. Richter:

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.

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

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Page 2 - Mr. William Richter

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

A. B. Rte

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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## Indications for Use

510(k) Number (if known):

Device Name: HiRoller Elevating Wheelchair

DEC 2 3 2010

Indications For Use:

The HiRoller Elevating Wheelchair is a product that allows wheelchair users to raise and lower their seat height while seated in the wheelchair.

## Target Population:

The HiRoller is designed for anyone who requires a manual wheelchair for mobility, including people with spinal cord injuries, cerebral palsy, multiple scherosis, muscular dystrophy, polio and spina bifida.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K102837