SMARTDRIVE WHEELCHAIR POWER-ASSIST

K113621 · Max Mobility, LLC · ITI · Jul 6, 2012 · Physical Medicine

Device Facts

• Record ID: K113621
• Device Name: SMARTDRIVE WHEELCHAIR POWER-ASSIST
• Applicant: Max Mobility, LLC
• Product Code: ITI · Physical Medicine
• Decision Date: Jul 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The SmartDrive is intended to provide power-assist to manual wheelchairs, empowering disabled persons, including pediatrics, capable of operating a powered and manual wheelchair by providing a means of enhanced mobility.

Device Story

SmartDrive is a power-assist device for manual wheelchairs; provides motorized propulsion to assist user mobility. Device attaches to manual wheelchair; operated by user to reduce physical effort required for propulsion. Intended for disabled individuals, including pediatric patients, capable of operating manual wheelchairs. Benefits include increased mobility and reduced fatigue. Used in various environments where manual wheelchairs are appropriate.

Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

Technological Characteristics

Powered wheelchair accessory; provides motorized assist to manual wheelchair frames. Class II device (CFR 890.3860).

Indications for Use

Indicated for disabled persons, including pediatric patients, capable of operating a manual wheelchair who require power-assist for enhanced mobility.

Regulatory Classification

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)

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## Public Health Service

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

Max Mobility, LLC % Mark Richter, Ph.D. President 5425 Mount View Parkway Antioch Tennessee 37013

6 2012 JUL

Re: K113621

Trade/Device Name: SmartDrive Wheelchair Power-Assist Regulation Number: CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: June 18, 2012 Received: June 19, 2012

Dear Dr. 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. 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

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Page 2 - Dr. Mark Richter

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.

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 (2.1 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 yours,

son

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 (revised)

510(k) Number (if known): K113621

Device Name: SmartDrive Wheelchair Power-Assist

Indications For Use:

The SmartDrive is intended to provide power-assist to manual wheelchairs, empowering disabled persons, including pediatrics, capable of operating a powered and manual wheelchair by providing a means of enhanced mobility.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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

510(k) Number K113621