(301 days)
Not Found
Not Found
No
The description focuses on mechanical and electrical components, safety features, and performance testing against established standards. There is no mention of AI, ML, or any features that would typically utilize such technologies.
No
A therapeutic device is used to treat or cure a medical condition. This device is a mobility aid designed to increase personal mobility and independence, rather than to treat a medical condition.
No
The device is a mobility scooter designed to assist users with personal mobility, not to diagnose or provide information related to a disease or health condition.
No
The device description clearly details a physical power scooter with hardware components like wheels, brakes, batteries, and a motor. It is not solely software.
Based on the provided text, the Mega 3 scooter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to increase personal mobility for individuals with limited mobility or those who prefer riding to walking. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a power scooter with features related to mobility, handling, braking, and user comfort. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring specific substances (analytes) in these samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The Mega 3 scooter is clearly a mobility aid, falling under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Mega 3 scooter is intended to help the user achieve a more independent lifestyle by increasing their personal mobility. The Mega 3 scooter is intended for use by people who due to medical reasons, accident, or injury do not have adequate mobility to lead the active lifestyle they want. It is also intended for any person who would simply rather ride a scooter than walk.
Product codes (comma separated list FDA assigned to the subject device)
89INI
Device Description
The Mega 3 is a three-wheel power scooter designed to help people with poor mobility lead a more active lifestyle. The fact that this is a 3-wheel scooter with a sharp turning radius makes it ideal for indoor use and cornering in close quarters. The Mega 3 scooter is also ideal for outdoor use as it is capable of traversing bumpy or uneven terrain.
The Mega 3 is a three-wheel scooter with exceptional handling and is quiet due to the use of pneumatic tires and a sealed transaxle as opposed to a separate motor, differential, and chain application. It is equipped with two kinds of brakes: dynamic regenerative and a parking brake. The electronic parking brake is normally on and is released when the driver moves the throttle lever. When the driver releases the throttle lever, the regenerative braking will slow the scooter to a stop and the parking brake will be activated 1/2 second thereafter, holding the scooter, preventing any movement. The electronic controller of the Mega 3 has a water-resistant casing with no exposed wires. This feature protects the electronics from environmental damage and corrosion.
The Mega 3 Scooter's maximum forward speed is 5.0mph. The maximum speed in reverse is 60% of the maximum forward speed or 3.0mph. The speed in reverse is reduced for safety purposes as it is more difficult to negotiate a scooter in reverse motion than in forward motion. The speeds are regulated in two ways: a throttle lever and a speed potentiometer.
The Mega 3 has several user-friendly features. It comes equipped with an external freewheeling release lever, external battery charger jack, and an external circuit breaker reset button all for easy accessibility. It has a special light-weight-seat (21 lbs.) for easy disassembly and transportation. The seat is adjustable up and down, swivels 360°, and has flip up arms. The Mega 3 is equipped with two lateral and two rear high visibility reflectors to increase the scooter's visibility. This feature, as well as the anti-tip wheels located 1 1/2" from the ground on the rear of the scooter, provide added safety for the passenger. The Mega 3 has an adjustable tiller for user comfort and easy transportation.
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 Mega 3 power scooter was tested in accordance with the ANSI/RESNA Standard, Wheel chairs - Testing of Power and Control Systems for Electric Wheelchair. WC/14, December 1991, parts 00, 01, 02, 03, 05, and 10 and passed. Results of these tests are included in section 6 of this 510(k) application package.
No clinical tests were submitted with the premarket notification for the Mega 3 power scooter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Mega 3 power scooter is substantially equivalent in safety, efficacy, technology, and intended use to the Pace Saver Plus III Premier, currently marketed by Leisure Lift.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
KQ8214S$
P.O. Box 3744 Scranton, PA 18505-0744 Phone: 1-888-415-1200 Fax: 1-888-415-1210
1002
510 (K) Application-Section 8 510 (K) Summary
- 510 (K) Summary
Image /page/0/Picture/5 description: The image appears to be a black and white illustration or map, possibly depicting a landmass or geographical region. The details are rendered in a pointillist style, with small dots creating the shapes and textures. The overall impression is somewhat abstract due to the density and distribution of the dots, but it suggests a coastline or the outline of a continent.
APR 14
Inc. "Products for Better Living lotior
1
P.O. Box 3744 Scranton, PA 18505-0744 Phone: 1-888-415-1200 Fax: 1-888-415-1210
510(k) Summary
(1) Submitter's name & address: a)
Mega Motion, Inc. P.O. Box 3744 Scranton, PA 18505-3744
Date of preparation of this summary:
(2) Device trade or proprietary name Device common or usual name or classification name: Classification Number:
582
Contact person:
Paul Gronka Official Correspondent 1-888-415-1200
June 15, 1998
Mega 3 scooter 3-wheel power scooter 89INI
(3) Substantial Equivalence:
The Mega 3 power scooter is substantially equivalent in safety, efficacy, technology, and intended use to the Pace Saver Plus III Premier, currently marketed by Leisure Lift.
(4) Description of the new device:
The Mega 3 is a three-wheel power scooter designed to help people with poor mobility lead a more active lifestyle. The fact that this is a 3-wheel scooter with a sharp turning radius makes it ideal for indoor use and cornering in close quarters. The Mega 3 scooter is also ideal for outdoor use as it is capable of traversing bumpy or uneven terrain.
The Mega 3 is a three-wheel scooter with exceptional handling and is quiet due to the use of pneumatic tires and a sealed transaxle as opposed to a separate motor, differential, and chain application. It is equipped with two kinds of brakes: dynamic regenerative and a parking brake. The electronic parking brake is normally on and is released when the driver moves the throttle lever. When the driver releases the throttle lever, the regenerative braking will slow the scooter to a stop and the parking brake will be activated 1/2 second thereafter, holding the scooter, preventing any movement. The electronic controller of the Mega 3 has a water-resistant casing with no exposed wires. This feature protects the electronics from environmental damage and corrosion.
The Mega 3 Scooter's maximum forward speed is 5.0mph. The maximum speed in reverse is 60% of the maximum forward speed or 3.0mph. The speed in reverse is reduced for safety purposes as it is more difficult to negotiate a scooter in reverse motion than in forward motion. The speeds are regulated in two ways: a throttle lever and a speed potentiometer.
The Mega 3 has several user-friendly features. It comes equipped with an external freewheeling release lever, external battery charger jack, and an external circuit breaker reset button all for easy accessibility. It has a special light-weight-seat (21 lbs.) for easy
Mega Motions, Inc. “Products for Better Living” . . .
2
disassembly and transportation. The seat is adjustable up and down, swivels 360°, and has flip up arms. The Mega 3 is equipped with two lateral and two rear high visibility reflectors to increase the scooter's visibility. This feature, as well as the anti-tip wheels located 1 1/2" from the ground on the rear of the scooter, provide added safety for the passenger. The Mega 3 has an adjustable tiller for user comfort and easy transportation.
Electromagnetic interference (EMI) is the energy signals given off by any transmitting device such as CB radios and Cellular phones. These signals may cause erratic behavior in other electronic equipment operating nearby. This includes scooters. There is a caution sticker on the tiller to remind the user to use caution when riding the Mega 3 scooter and not to use communication equipment while the scooter is turned on. The Mega 3 has been EMI tested and passed at an immunity level of 20 V/m. While there is no way to tell if the scooter is totally safe, an immunity level of 20V/m (May '94) is generally achievable and useful. The results of the EMI testing performed on the Mega 3 scooter are included in section 6 of the 510(k)-application package.
The Mega 3 scooter has an on board charger as standard equipment. The charger has passed the minimum voltage ground leakage as required by the FDA/U.L. Certification from the charger supplier is included in section 4 of the 510(k)-application package.
The Mega 3 uses two 12-Volt 31 Amp sealed lead acid batteries. Certifications from the battery supplier that the batteries used on the Mega 3 meet the requirements of 49CFR173.159(d) and Special Provision A67 of the IATA Dangerous Goods Regulations for non-spillable batteries and are therefore, unrestricted for transportation by any means are enclosed in section 4 of this 510(k)-application package.
(5) Intended use of the device:
The Mega 3 scooter is intended to help the user achieve a more independent lifestyle by increasing their personal mobility. The Mega 3 scooter is intended for use by people who due to medical reasons, accident, or injury do not have adequate mobility to lead the active lifestyle they want. It is also intended for any person who would simply rather ride a scooter than walk.
| (6) Mega 3 Specifications | |
|---|---|
| Length: | 46" |
| Width: | 24" |
| Turning radius: | 32" |
| Maximum Speed: | 5.0 mph |
| Weight capacity: | 250 lbs. |
| Maximum range: | 20-25 miles |
| Tire type (front): | 9" x 4" pneumatic |
| Tire type (rear): | 10" x 4" pneumatic |
| Rear weight: | 45 lbs. |
| Seat weight: | 21 lbs. |
| Base/Tiller weight: | 32.5 lbs. |
| Battery weight: | 24 lbs. (each) |
| Battery type: | Two 12-Volt 31 amp (sealed |
| Battery charger: | On-board |
3
b)
- (1) Summary of nonclinical tests submitted with the premarket notification for the device. The Mega 3 power scooter was tested in accordance with the ANSI/RESNA Standard, Wheel chairs - Testing of Power and Control Systems for Electric Wheelchair. WC/14, December 1991, parts 00, 01, 02, 03, 05, and 10 and passed. Results of these tests are included in section 6 of this 510(k) application package.
(2) Summary of clinical tests submitted with the premarket notification for the device. b)
No clinical tests were submitted with the premarket notification for the Mega 3 power scooter.
(3) Conclusions drawn from the clinical and nonclinical trials. b)
Analysis of the comparison of design, function, and features of the Mega 3 power scooter to other devices currently legally marketed for the same intended use, together with the results of testing conducted to access the Mega 3 power scooter's compliance with existing ANSI/RESNA standards for powered wheelchairs demonstrates the Mega 3 to be substantially equivalent to these predicate devices in terms of safety, efficacy, intended use and technology.
4
Page 2 - Mr. Paul Gronka
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Whitton, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures