(15 days)
Not Found
No
The 510(k) summary describes a basic electric scooter with manual controls and no mention of AI or ML features.
No
The device is described as an indoor/outdoor transportation vehicle for mobility, not to treat or cure a disease or condition. Its intended use is to provide mobility to disabled or elderly persons, which is an assistive function rather than a therapeutic one.
No
The device description indicates it is a transportation vehicle for mobility, not designed to diagnose any medical condition.
No
The device description clearly states it is a battery-operated scooter with a tiller handle and throttle control, indicating it is a physical hardware device, not software only.
Based on the provided information, the ForU EQ30 scooter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to disabled or elderly persons. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The device description details a motor-driven scooter for transportation. 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 biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Diagnosing, monitoring, or predicting disease
- Using reagents or assays
The ForU EQ30 scooter is clearly described as a mobility aid, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
ForU EQ30 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
The ForU EQ30 scooter is motor driven, indoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
89INI
Device Description
The ForU EQ30 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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
disabled or elderly persons
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)
Not Found
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.
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
Image /page/0/Picture/1 description: The image shows a logo with a stylized letter 'K' inside an oval shape. The 'K' is bold and black, contrasting with the white background of the oval. The oval itself is outlined in black, creating a clean and simple design. The logo appears to be for a company or organization whose name starts with the letter 'K'.
KWANG YANG MOTOR CO., LTD.
No. 35, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan TEL: +886-7-3822526 FAX: +886-7-3825834
510(k) Summary
Device
OCT 3 2007
Trade name: ForU EQ30 scooter Common name: Electrical scooter
Classification name: Motorized three-wheeled vehicle
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3800
Product Code: 89INI
Classification: Class II
Predicate devices
AVANTICARE SA4022(K051538)/ LERADO CHINA LIMITED
Intend use of device
ForU EQ30 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
The ForU EQ30 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
Substantial equivalence:
The ForU EQ30 scooter is substantially equivalent to the AVANTICARE SA4022 (K051538) manufactured by LERADO CHINA LIMITED.
There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, KWANG YANG MOTOR CO., LTD. believes that the ForU EQ30 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
1
Image /page/1/Picture/0 description: The image shows a symbol that appears to be a stylized representation of a crescent moon within an oval. The crescent moon is positioned at the top of the oval, and there is a horizontal bar or line below it, inside the oval. The symbol is rendered in black against a white background, giving it a stark and simple appearance.
KWANG YANG MOTOR CO., LTD.
No. 35, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan
5, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan
TEL: +886-7-3822526 FAX: +886-7-3825834
The substantial equivalence comparison of the ForU EQ30 and SA4022
| SA4022(K051538) | ForU EQ30 | |
|---|---|---|
| Intended use | Three scooters are motor driven, indoor and outdoor transportation vehicles with the intended use to provide | |
| mobility to disabled or elderly persons limited to a seated position. | ||
| Maximum loading | 135 kg (300 lbs) | 150 kg (330 lbs) |
| Overall height | 980 mm (38.5") | 1250 mm (49.2") |
| Overall length | 1160 mm (45.7") | 1240 mm (48.8") |
| Overall width | 540 mm (21.3") | 560 mm (22") |
| Seat overall height | 520 mm (20.5") | 756 mm (29.8") |
| Seat overall width | 457 mm (18") | 455 mm (17.9") |
| Seat overall depth | 406 mm (16") | 400 mm (15.7") |
| Seat overall weight | 15 kg (33 lbs) | 15.2 kg(33.4 lbs) |
| Motor output | 350W x DC24V × 5100 RPM, 1PC | 350W x DC24V × 1PC |
| Controller | Dynamic DS72K01 | KYSA 70 |
| Differential | ||
| mechanism | Differential rate: 19.7 : 1 | |
| Rear wheel drive | Sealed transaxle direct drive | |
| Operation mode | Thumb operated potentiometer throttle control lever | |
| Battery | Lead-Acid 12V × 36AH × 2PCs | Lead-Acid 12V x 31 AH × 2PCs |
| Battery level | ||
| indicator | Yes | |
| The substantial equivalence comparison of the ForU EQ30 and SA4022 | ||
| (Continuous) | SA4022(K051538) | ForU EQ30 |
| Charger | HP 24V 3/5AMP (Automatic Type) off-board | HP 24V, 5 AMP (Automatic Type) on-board |
| Front wheel | 10" x 2" foam filled tire × 2 PCs | |
| Rim: aluminum alloy | 10" x 5" pneumatic tire × 2 PCs | |
| Bumpers | Front/Rear: It's constructed by engineering plastics | Front: It's constructed by steel tube |
| Rear: It's constructed by engineering plastics | ||
| Armrest | Yes, Foldable | |
| Tiller foldable | Yes | |
| Backrest recline | Yes | |
| Recline angle | ||
| indicator | No | |
| Headrest | No | |
| Height adjustable | No | |
| Rear wheel | 10" x 2" foam filled tire × 2 PCs | |
| Rim: aluminum alloy | 10" x 5" pneumatic tire × 2 PCs | |
| Break system | Intelligent regenerative electromagnetic brake and hand brake | |
| Braking distance | 1.88 m (74") | Forward: 1.24 m (48.8") at max speed |
| Net weight with | ||
| battery | 81 kg (178 lbs) | 84.4 kg(185.7 lbs) |
| Slope grade ability | 12 degree | 10 degree |
| Continuous | The substantial equivalence comparison of the ForU EQ30 and SA4022 | |
| SA4022(K051538) | ForU EQ30 | |
| Per-charge distance | 35 km (22 miles) | Up to 37 km (23.1 miles) |
| Maximum speed | 8.5 km/h (5.3 mph) | Up to 8 km/hr (4.7 mph), variable |
| Speed mode | Single mode, Variable | |
| Turning radius | 1450 mm (57") | 1565 mm (61.6") |
| Maximum curb | ||
| height | 90 mm (3.5") | 80 mm (3.14") |
| Suspension | Front: No, | Rear: Yes |
| Head/Tail lights | ||
| Signal light | Head/tail lights and | |
| Signal light | signal lights of the EQ30 and SA4022 scooters have the same functions, but only the | |
| styles are different. | ||
| Warning light | Yes | |
| Horn | Yes | |
| Anti-tip wheels | Yes |
7-2
2
KWANG YANG YANG MOTOR CO., LTD.
6. 35, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan
F
TEL: +886-7-3825226 FAX: +886-7-3825834
MIRASYS, 4, ANMIN ST., SAN MIN DIST., KAOHSIUNG, TAIWAN
3
Image /page/3/Picture/0 description: The image shows a black and white symbol that resembles an eye. The symbol is enclosed in an oval shape. Inside the oval, there is a crescent shape above a horizontal line.
KWANG YANG MOTOR CO., LTD.
No. 35, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan
TEL: +886-7-3822526 FAX: +886-7-3825834
5, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan
TEL: +886-7-3822526 FAX: +886-7-3825834
The substantial equivalence comparison of the ForU EQ30 and SA4022
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes extending diagonally upwards and to the right. The eagle is positioned above a wavy line, which may represent water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
0CT 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KWANG YANG MOTOR CO., LTD. % Ms. Juannata Chang No. 35, Wan Hsing Street San Min Dist., 803 Kaohsiung, Taiwan
Re: K072630 Trade/Device Name: ForU EQ30 Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 10, 2007 Received: September 18, 2007
Dear Ms. Chang:
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. Iisting 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.
5
Page 2 -- Ms. Juannata Chang
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 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,
Neil R. B. Oyler
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
- Device descriptive information
3.1 Statement of indication for use
Statement of Indications for Use
510(k) Number (if known): _
Device Name: ForU EQ30
Indications for Use:
The ForU EQ30 scooter is motor driven, indoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (Part 21 CFR 807 Subpart C) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Nil R.P. Oglin for mxm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K072630
(Posted November 13, 2003)