(27 days)
Not Found
No
The summary describes a powered wheelchair focused on mobility and portability, with no mention of AI or ML features.
No
The device is a powered wheelchair for transportation and mobility, not for treating or diagnosing diseases or conditions.
No
The device is described as a powered wheelchair for mobility, not for diagnosing medical conditions.
No
The device description clearly states it is a "powered wheelchair" which is a physical hardware device with motors and a battery pack.
No, this device 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 description details a powered wheelchair for transportation, not a device used to examine specimens.
- 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 substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
This device is clearly a mobility aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ITI
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.
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
CWD01 (K062888)
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
§ 890.3860 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).
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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.
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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 transportation | |
| vehicles with the intended use to provide mobility to | ||
| disabled or elderly persons limited to a seated position. | It is intended for medical purposes to provide | |
| mobility 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 distance | ||
| Forward: 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 piece | ||
| weight | 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 curb | ||
| height | 80 mm (3.147") | |
| Suspension | Front/Rear: No, Middle: Yes | Cross brace |
| Horn | Yes |
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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
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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.
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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
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- 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)