FREEDOM SCIENCES MOTION CONTROL MODULE (MCM)

K073330 · Freedom Sciences, LLC · ITI · Jun 20, 2008 · Physical Medicine

Device Facts

• Record ID: K073330
• Device Name: FREEDOM SCIENCES MOTION CONTROL MODULE (MCM)
• Applicant: Freedom Sciences, LLC
• Product Code: ITI · Physical Medicine
• Decision Date: Jun 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Indications for Use

The intended use of the Freedom Sciences MCM is to enable the remote motion control of a powered wheelchair only while the wheelchair is unoccupied. It is not intended for use while the person is seated in the wheelchair.

Device Story

Freedom Sciences Motion Control Module (MCM) is a wireless remote control for powered wheelchairs; enables remote operation only when wheelchair is unoccupied. Device interfaces with host wheelchair attendant control interface on motor controller; utilizes existing safety interlocks inherent to host controller. Used by caregivers or users to reposition unoccupied wheelchairs. Output consists of high-level motion control commands to wheelchair motor controller. Benefits include improved convenience for wheelchair positioning without occupant.

Clinical Evidence

Bench testing only. The device was tested according to the FDA's July 26, 1995, draft guidance document for mechanical and powered wheelchairs. The MCM met all applicable performance criteria.

Technological Characteristics

Wireless remote control module for powered wheelchairs. Interfaces via host wheelchair attendant control interface on motor controller. Retains host-inherent safety interlocks. Standard auxiliary input integration. No specific materials or software architecture details provided.

Indications for Use

Indicated for remote motion control of unoccupied powered wheelchairs. Not for use when a person is seated in the wheelchair.

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.

Predicate Devices

• Dynamic Systems, Inc. PHC-2 Peachtree Proportional Head Control Unit (K972147)
• Sunrise Medical Breath Control (K983520)

Submission Summary (Full Text)

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K073330

JUN 2 0 2008

510(k) Premarket Notification

Freedom. In Motion Control Module

## 510(k) SUMMARY

Freedom Sciences LLC Motion Control Module

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Freedom Sciences, LLC The Navy Yard - Quarters M2 4601 South Broad Street Philadelphia, PA 19112

Contact Person: Edward A. Kroll Representative Consultant for Freedom Sciences, LLC

Date Prepared: November 15, 2007

Name of Device and Name/Address of Sponsor

Freedom Sciences Motion Control Module (MCM)

Freedom Sciences, LLC The Navy Yard - Quarters M2 . 4601 South Broad Street Philadelphia, PA 19112

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Common or Usual Name

Power Wheelchair

Classification Name

Wheelchair, Powered

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510(k) Premarket Notification

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Freedom ... Motion Control Module

# Predicate Devices

Dynamic Systems, Inc. PHC-2 Peachtree Proportional Head Control Unit (K972147) and the Sunrise Medical Breath Control (K983520).

### Intended Use

The intended use of the Freedom Sciences MCM is to enable the remote motion control of a powered wheelchair only while the wheelchair is unoccupied. It is not intended for use while the person is seated in the wheelchair.

### Technological Characteristics and Substantial Equivalence

### A. Device Description

The Freedom Sciences Motion Control Module for powered wheelchairs is a wireless, remote control product designed for use with powered wheelchairs. Its intended function and use is to allow for remote motion control of a powered wheelchair only while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.

The MCM allows for remote motion control of a differential drive power wheelchair using high level motion control commands. It interfaces to the power wheelchair using the host wheelchair attendant control interface on the motor controller. This method of interfacing with the powered wheelchair retains all configured safety interlocks inherent to the host motor controller itself and is the standard means for integrating auxiliary input devices.

#### B. Substantial Equivalence

Products which are substantially equivalent to the MCM are the Dynamic Systems, Inc. PHC-2, Peachtree Proportional Head Control Unit (K972147) and the Sunrise Medical Breath Control (K983520).

#### Performance Data

The MCM was tested as required by FDA's July 26, 1995, draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and

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FreedomObian 18: Motion Control Module

510(k) Premarket Notification

Motorized Three- Wheeled Vehicles". The Freedom Sciences MCM met the applicable required performance criteria and functioned as intended.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Freedom Sciences, LLC % Spectre Solutions, Inc. Mr. Edward A. Kroll Representative Consultant 5905 Fawn Lane Cleveland, Ohio 44141

JUN 2 0 2008

Re: K073330 Trade/Device Name: Freedom Sciences, LLC Motion Control Module (MCM)

Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 2, 2008 Received: June 4, 2008

Dear Mr. Kroll:

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 such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elcctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Edward A. Kroll

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

lf 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): 彌爾 (073330

Device Name: Freedom Sciences, LLC Motion Control Module (MCM)

Indications for Use:

The intended use of the Freedom Sciences Motion Control Module is to allow for remote motion control of a powered wheelchair while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nilfeah for mxs

(Division of General, Restorative, and Neurological Devices

510(k) Number K073330

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