(27 days)
The ForU KV10HB powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The ForU powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. But the ForU KV10HB is kind oh a new class of lightweight powered wheelchair. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
This document is a 510(k) premarket notification for the ForU KV10HB powered wheelchair, seeking substantial equivalence to a predicate device (CWD01, K062888). As such, it primarily focuses on comparing specifications to demonstrate equivalence rather than presenting an independent study with defined acceptance criteria and performance metrics for the ForU KV10HB in isolation.
Therefore, many of the requested elements regarding acceptance criteria, study details, and ground truth establishment are not directly applicable or explicitly stated in this type of regulatory submission. The goal here is to show similarity to an already approved device, not necessarily to prove independent performance against specific thresholds in a detailed clinical or technical study.
However, based on the provided text, I can extract information related to the comparison table and address the relevant questions.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria in a 510(k) submission are implicitly defined by the specifications of the predicate device. The applicant essentially claims that their device's performance is "substantially equivalent" to the predicate, meaning any differences do not raise new questions of safety or effectiveness. The table below presents the comparative data provided. An "acceptance criterion" column is added, reflecting the predicate's performance, and the "reported device performance" reflects the ForU KV10HB.
| Feature / Performance Metric | Acceptance Criterion (CWD01 K062888) | Reported Device Performance (ForU KV10HB) |
|---|---|---|
| Intended Use | Medical purposes to provide mobility to persons restricted to a sitting position. | 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 | 136 kg (300 lbs) | 165 kg (350 lbs) |
| Overall Height | 1130 mm (44.5") | 1140 mm (44.9") |
| Overall Length | 900 mm (35.4") | 1032 mm (40.6") |
| Overall Width | 650 mm (25.6") | 644 mm (25.4") |
| Motor Output | 260W x DC24V × 2Pcs | DC 24V, 200 W, 2 Pcs |
| Controller | Dynamic Shark | PG VR2 |
| Battery | Lead-Acid 12V × 35AH × 2PCs | Gel/Seal Lead-Acid 12V × 50AH × 2PCs |
| Charger | DC 24V 5A, off-board | DC 24V 5 AMP (Automatic Type) on-board |
| Front/Rear Wheel | 6" pneumatic tire × 2 PCs | 6" Solid tire × 2 PCs |
| Middle Wheel | 10" PU foaming tire × 2 PCs | 12.8" Solid tire × 2 PCs |
| Armrest | Removable | Fixed |
| Break system | Intelligent regenerative electromagnetic brake | Braking distance Forward: 0.9 m (35.4") at max speed |
| Net Weight (w/ batteries) | 83.5kg (183.7 lbs) | 98 kg (215.6 lbs) |
| Slope Grade Ability | 12 degree | 10 degree |
| Per-charge Distance | 40 km (24 miles) | Up to 37 km (23.1 miles) |
| Maximum Speed | 5 km/h (3.2 mph) | Up to 6.5 km/hr (4.1 mph), variable |
| Suspension | Cross brace | Front/Rear: No, Middle: Yes |
| Horn | Yes | (Not explicitly stated for ForU KV10HB in table, implying difference or absence) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a regulatory comparison for substantial equivalence, not a clinical trial or performance study with a "test set" of individuals or a defined dataset. The "data provenance" is the manufacturer's self-reported specifications for their device (ForU KV10HB) and specifications for the predicate device (CWD01) as understood from its 510(k) submission. Both devices are manufactured in Taiwan, suggesting the data originates from Taiwan. It is a comparison of device specifications, not retrospective or prospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Applicable to clinical studies, not product specification comparisons. No experts were explicitly mentioned as establishing "ground truth" for the comparative data presented. The "ground truth" here is the published specifications of the predicate device and the manufacturer's own specifications for their new device.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" in the sense of clinical cases or data requiring adjudication. The comparison is based on published and self-declared device specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a 510(k) submission for a physical medical device (powered wheelchair), not an AI or imaging device that would typically undergo an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device. The submission focuses on the physical and functional aspects of a powered wheelchair.
7. The Type of Ground Truth Used
The "ground truth" for this submission are the published design specifications and performance characteristics of the predicate device (CWD01) and the newly submitted device (ForU KV10HB). This includes physical dimensions, motor specifications, battery type, speed, range, and weight.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. This is not a machine learning or AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8.
{0}------------------------------------------------
AUG 2 0 2007
Image /page/0/Picture/2 description: The image shows a logo with a stylized letter 'K' inside an oval shape. The 'K' is bold and black, and it appears to be slightly tilted. The oval shape surrounding the 'K' is also black, creating a simple and recognizable design.
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
Trade name: ForU KV10HB powered wheelchair
Common name: Powered wheelchair
Classification name: Powered wheelchair
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3860
Product Code: ITI
Classification: Class II
Predicate devices
CWD01 (K062888) / EMG Technology Co. Ltd.
Intend use of device
ForU KV10HB powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
The ForU powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. But the ForU KV10HB is kind oh a new class of lightweight powered wheelchair. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
Substantial equivalence:
The ForU KV10HB powered wheelchair is substantially equivalent to the CWD01 (K062888) manufactured by EMG Technology Co. Ltd..
There are minor differences in performance specifications of the powered wheelchairs, 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 KV10HB powered wheelchair is substantially equivalent to legally marketed devices currently in commercial distribution.
{1}------------------------------------------------
1
KWANG YANG MOTOR CO., LTD. CO., LTD.
No. 35, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan
TEL: +886-7-3822526 FAX: +886-7-3825834
A. PAUL LUSTIG, SUITE 360, 1415 DIS., INC., LAWRENCE, KS 66049
TEL: +1-886-7-382526 FAX: +1-886-7-382534
The substantial equivalence comparison of the ForU KV10HB and CWD01
| ForU KV10HB | CWD01 (K062888) | |
|---|---|---|
| Intended use | It is motor driven, indoor and outdoor transportationvehicles with the intended use to provide mobility todisabled or elderly persons limited to a seated position. | It is intended for medical purposes to providemobility to persons restricted to a sitting position. |
| Maximum loading | 165 kg (3501bs) | 136 kg (300 lbs) |
| Overall height | 1140 mm (44.9") | 1130 mm (44.5") |
| Overall length | 1032 mm (40.6") | 900 mm (35.4") |
| Overall width | 644mm (25.4") | 650 mm (25.6") |
| Seat overall height | 600 mm (23.6") | |
| Seat overall width | 800 mm (31.5") | 18" |
| Seat overall depth | 500 mm (19.7") | |
| Seat overall weight | 21 kg (46.2 lbs) | |
| Motor output | DC 24V, 200 W, 2 Pcs | 260W x DC24V × 2Pcs |
| Controller | PG VR2 | Dynamic Shark |
| Rear wheel drive | Sealed transaxle direct drive | |
| Battery | Gel/Seal Lead-Acid 12V × 50AH × 2PCs | Lead-Acid 12V×35AH×2PCs |
| Charger | DC 24V 5 AMP (Automatic Type) on-board | DC 24V 5A, off-board |
| Front/Rear wheel | 6" Solid tire × 2 PCs | 6" penumatic tire × 2 PCs |
| Middle wheel | 12.8" Solid tire × 2 PCs | 10" PU foaming tire × 2 PCs |
| Continuous) | The substantial equivalence comparison of the ForU KV10HB and CWD01 | |
| ForU KV10HB | CWD01 (K062888) | |
| Armrest | Fixed | Removable |
| Break system | Intelligent regenerative electromagnetic brake | |
| Braking distanceForward: 0.9 m(35.4") at max speed | ||
| Net weight w | 83.5kg (183.7 lbs) includes batteries | |
| Battery | 98 kg (215.6 lbs) | |
| Heaviest pieceweight | 44 kg (96.8 lbs.) body frame with motor | |
| Slope grade ability | 10 degree | 12 degree |
| Per-charge distance | Up to 37 km (23.1 miles) | 40 km (24 miles) |
| Maximum speed | Up to 6.5 km/hr (4.1 mph), variable | 5 km/h (3.2 mph) |
| Turning radius | 515 mm (20.3") | |
| Maximum curbheight | 80 mm (3.147") | |
| Suspension | Front/Rear: No, Middle: Yes | Cross brace |
| Horn | Yes |
7-2
{2}------------------------------------------------
C
KWANG YANG MOTOR CO., LTD.
No. 35, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan
TEL: +886-7-3822526 FAX: +886-7-3825834
TEL: +886-3-3827556 FAX: +886-3-3825834
TEL: +886-3-3825226 FAX: +886-3-3825308
7-3
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three abstract, wave-like forms, and the text is in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kwang Yang Motor Co., Ltd. % Mr. Yen, Wen Hsi No. 35, Wan Hsing Street San Min Dist., 803 Kaohsiung, Taiwan
AUG 2 0 2007
K072027 Re: Trade/Device Name: ForU KV10HB Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: July 20, 2007 Received: July 24, 2007
Dear Mr. Yen, Wen Hsi:
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.
{4}------------------------------------------------
Page 2 - Mr. Yen, Wen Hsi
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/cdrb/industry/support/index.html.
Sinc
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
- Device descriptive information
3.1 Statement of indication for use
Statement of Indications for use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ForU KV10HB
Indications for use:
The ForU KV10HB powered wheelchair is motor driven, indoor and outdoor 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) | AND/OR | (Part 21 CFR 807 Subpart C) | |||
| (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 | ||||
| (Division Sign-Off) | |||||
| Division of General, Restorative,and Neurological Devices | |||||
| 510(k) Number | I2072027 |
(Posted November 13, 2003)
§ 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).