(206 days)
Not Found
No
The description focuses on remote control and interfacing with the wheelchair's existing motor controller, with no mention of AI/ML terms or capabilities.
No
The device is a remote control module for wheelchairs, not a device used for medical treatment or diagnosis for a patient. Its intended use is to move an unoccupied wheelchair.
No
The document explicitly states that the device is for "remote motion control of a powered wheelchair" and is "not intended for use when a person is seated in the wheelchair," which indicates it controls equipment rather than performing any diagnostic function on a person.
No
The device description explicitly states it is a "wireless, remote control product" and interfaces with the wheelchair using the "host wheelchair attendant control interface on the motor controller." This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control the motion of a powered wheelchair when it is unoccupied. This is a mechanical/electrical control function, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on the remote control functionality and its interface with the wheelchair's motor controller. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Predicate Devices: The predicate devices listed are also related to wheelchair control (head control unit, breath control), not diagnostic devices.
Therefore, the Freedom Sciences Motion Control Module is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / 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.
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.
Product codes
ITI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Motorized Three- Wheeled Vehicles". The Freedom Sciences MCM met the applicable required performance criteria and functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3860 Powered wheelchair.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
1
510(k) Premarket Notification
Image /page/1/Picture/1 description: The image shows a black and white graphic with a pattern of alternating black and white squares on the left side. The pattern appears to be disintegrating or fading out as it moves to the right, with the squares becoming smaller and more dispersed. The right side of the image is mostly white space with a few scattered black dots.
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
2
Image /page/2/Picture/0 description: The image shows a black and white graphic with a concentration of dark pixels in the upper left corner, resembling a checkered pattern or a dense cluster of objects. From this concentrated area, a scattering of individual dark pixels extends towards the right side of the image, gradually dispersing and becoming less dense. The background is plain white, providing a stark contrast to the dark pixels and emphasizing their distribution across the frame. The overall impression is one of dispersion or disintegration from a central point.
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.
3
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.
4
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 (240) 276-0120. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
5
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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