(26 days)
No
The device description and performance studies focus on standard mobility scooter features and safety testing, with no mention of AI or ML.
No
The device provides mobility to individuals with limited walking capabilities or for general transportation, which is not considered a therapeutic effect. It aids in daily living rather than treating or preventing a disease or condition.
No
Explanation: The device description and intended use clearly state that it is a powered scooter designed for mobility and transportation, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, battery-operated power scooter with hardware components like wheels, a controller, brakes, and batteries. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to individuals with limited walking capabilities or for transportation. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a powered scooter with features related to mobility, safety, and portability. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting diseases, conditions, or states of health.
- Using reagents, assays, or laboratory procedures.
The device is clearly a mobility aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The intended use of the Mega Motion, Inc, Travel Pal Powered Scooter is to provide mobility to persons that have limited walking capabilities or simply those who wish to ride a scooter for transportation purposes.
Product codes
INI
Device Description
The Travel Pal is a compact battery-operated Three Wheel power Scooter featuring rear anti-tip wheels, a standard digital controller, and a foldable tiller. The Travel Pal is designed for, but not limited to Mega Motion, Inc. providers / retailers and their consumers.
As a motorized Scooter, the Travel Pal offers economical mobility, and is equipped with; electronic regenerative disc brakes, off-board battery charger, and removable batteries. Accessories include a front basket.
The Travel Pal is designed with ultimate safety, stability, performance, and portability in mind. The product also has a lightweight, foldable seat, which is removable and allows for ease of portability when traveling or storing the unit.
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
Non-Clinical Testing:
Compliance to applicable Testing Standards is as follows: ANSI/RESNA WC/93 Maximum Overall Dimensions ANSI/RESNA WC/01 Determination of Static Stability ANSI/RESNA WC/02 Determination of Dynamic Stability ANSI/RESNA WC/03 Effectiveness of Brakes ANSI/RESNA WC/04 Determination of Energy Consumption - Theoretical Range ANSI/RESNA WC/05 Overall Dimensions, Mass & Turning Space ANSI/RESNA WC/08 Test methods for Static, Impact and Fatigue Strengths ANSI/RESNA WC/09 Climatic Tests ANSI/RESNA WC/10 Obstacle Climbing ANSI/RESNA WC/15 Documentation and Labeling ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility. CAL 117 - Flammability Testing
Discussion of Clinical Testing Performed:
N/A
Conclusions:
The Travel Pal has the same intended use and similar technological characteristics as the Mega3 (K982145), moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Travel Pal is substantially equivalent to the predicate device (Mega 3 MM333). The Travel Pal has passed all the necessary testing procedures and is considered to be safe for user operation.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo for Mega Motion, Inc. with the tagline "Products for Better Living". The image also contains the text "APR I ) 2006" and "Exhibit 1". The number K060697 is also present in the image.
Travel Pal 510(k) Summary
Submitter's Name & Address:
Mega Motion, Inc. 957 Wood Street Old Forge, Pa. 18518 Phone: (888) 415-1200 Facsimile: (888) 415-1210
Mark Calomino Official Correspondent
Date Prepared:
Contact Person:
Name of Device and Proprietary Name:
Common or Usual Name:
Classification Name:
03-02-06
Travel Pal (MM-111B) / Mega Motion
3-Wheel Power Scooter
Vehicle, Motorized 3-Wheeled
Product Code:
INI
Device Description:
The Travel Pal is a compact battery-operated Three Wheel power Scooter featuring rear anti-tip wheels, a standard digital controller, and a foldable tiller. The Travel Pal is designed for, but not limited to Mega Motion, Inc. providers / retailers and their consumers.
As a motorized Scooter, the Travel Pal offers economical mobility, and is equipped with; electronic regenerative disc brakes, off-board battery charger, and removable batteries. Accessories include a front basket.
The Travel Pal is designed with ultimate safety, stability, performance, and portability in mind. The product also has a lightweight, foldable seat, which is removable and allows for ease of portability when traveling or storing the unit.
Comparison to Predicate Devices:
The Travel Pal is substantially equivalent to Mega Motion, Inc. Mega3, MM-333 (K982145) when comparing configuration, maneuverability, stability, and structure. The performance characteristics and the position of the drive mechanisms are similar to achieve the same intended use function that enables
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Image /page/1/Picture/0 description: The image shows the logo for Mega Motion, Inc. The text "Mega Motion, Inc." is in a stylized font with a 3D effect. Below the logo is the tagline "Products for Better Living" in a simpler, sans-serif font.
the user to maintain optimum stability without hindering performance. Both utilize rear drive and rear anti-tip wheels. The key functional change between the Mega3 and the Travel Pal is the Travel Pal's frame is one piece, and batteries are accessible by shroud removal.
Intended Use:
The intended use of the Mega Motion, Inc, Travel Pal Powered Scooter is to provide mobility to persons that have limited walking capabilities or simply those who wish to ride a scooter for transportation purposes.
Non-Clinical Testing:
Compliance to applicable Testing Standards is as follows: ANSI/RESNA WC/93 Maximum Overall Dimensions ANSI/RESNA WC/01 Determination of Static Stability ANSI/RESNA WC/02 Determination of Dynamic Stability ANSI/RESNA WC/03 Effectiveness of Brakes ANSI/RESNA WC/04 Determination of Energy Consumption - Theoretical Range ANSI/RESNA WC/05 Overall Dimensions, Mass & Turning Space ANSI/RESNA WC/08 Test methods for Static, Impact and Fatigue Strengths ANSI/RESNA WC/09 Climatic Tests ANSI/RESNA WC/10 Obstacle Climbing ANSI/RESNA WC/15 Documentation and Labeling ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility. CAL 117 - Flammability Testing
Discussion of Clinical Testing Performed:
N/A
Conclusions:
The Travel Pal has the same intended use and similar technological characteristics as the Mega3 (K982145), moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Travel Pal is substantially equivalent to the predicate device (Mega 3 MM333). The Travel Pal has passed all the necessary testing procedures and is considered to be safe for user operation.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around it. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2006
Mega Motion, Inc. c/o Mr. Mark Calomino 957 Wood Street Old Forge, Pennsylvania 18518
Re: K060697
Trade/Device Name: Travel Pal - 3 Wheel Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: March 6, 2006 Received: March 16, 2006
Dear Mr. Calomino:
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Mark Calomino
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K
Device Name: Travel Pal - 3 Wheel Scooter
Indications for Use:
The intended use of the Mega Motion Inc., Travel Pal Powered Scooter, is to provide mobility to persons that have limited walking capabilities or simply those who wish to ride a scooter for transportation purposes.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND / OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OMDI
(Division Sign Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number_ko60697