(36 days)
Not Found
No
The description focuses on the mechanical aspects and standards compliance of a wheelchair, with no mention of AI or ML.
No
Explanation: A therapeutic device is used for treating or curing a disease or condition. This device provides mobility support and is not used for direct treatment.
No
Explanation: The device is a wheelchair intended for mobility, not for diagnosis of medical conditions.
No
The device description clearly describes a physical wheelchair with hardware components (base, wheels, seat, upholstery).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to persons restricted to a seated position. This is a physical function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The description details a wheelchair, a mechanical device for mobility. There is no mention of reagents, samples, or any components typically associated with in vitro diagnostics.
- Lack of IVD Indicators: The document does not mention any of the key 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 treatment decisions based on laboratory results.
This device is a mobility aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricts to a seated position.
Product codes
IOR
Device Description
The WH Convertible Lightweight Wheelchair WHL100 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
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
Performance Testing: ML-300 Foldable Wheelchair meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
Ko625/
January 26, 2006
Image /page/0/Picture/1 description: The image shows two white symbols against a black background. The symbols are similar in shape, resembling a stylized letter 'H' with additional curved elements extending upwards. The symbol on the left has a more angled appearance, while the one on the right is more rounded and symmetrical.
IF : No 2. Alley 12 Lane 89. Yonglong 2nd St., Dali City, Taichung County 412. Tawan 10.000 y [정 회 20159226 - Pay 04 20150209 I serad will homes a misu hind no ただけ、
2006
ell Home Health Produc
لقرار المقارمة المقارمة المقارمة المقارمة المقارمة المقاومة الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع ا
MAR 8
66 510(k) SUMMARY "
Submitter's Name: WELL HOME HEALTH PRODUCTS CO. 1F, No.2, Alley 12, Lane 89, Yonglong 2nd St., Daili City, Taichung County, Taiwan, 412, ROC
Date summary prepared:
Device Name:
Proprietary Name:
Common or Usual Name: Classification Name:
WH Convertible Lightweight Wheelchair, WHL100 Mechanical Wheelchair Mechanical Wheelchair, Class I, 21 CFR 890.3850
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricts to a seated position.
Description of the device:
The WH Convertible Lightweight Wheelchair WHL100 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
Performance Testing:
ML-300 Foldable Wheelchair meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
Legally marketed device for substantial equivalence comparison:
PRO WALKER ML-300 Foldable Wheelchair ( K041337 ).
() 1
1
Image /page/1/Picture/0 description: The image contains a logo for Well Home Health Products Co. The logo consists of the letters "W" and "H" in a stylized font, followed by the company name in English and Chinese. There is also a handwritten number "K060251" on the top right of the image. The text is slightly blurred, suggesting that the image may be a scan or a photograph of a document.
15 No 2 Alley 12 Lane 89, Yonglone 2nd St., Dali City, Taichung County 412, Lawan (R () ( ) 1:1-04-23159274 Tax 04 24359269 l'-maltuell bames a-msa hinet nei http://www.seal.ill/gears.com/
Summary for substantial equivalence comparison:
The intended use of the two devices is the same, and mainframes of two devices are the same foldable. The overall dimensions are similar. Back upholstery material is also the same resistance -ignitability fabric. The major differences existing are the overall dimension, and the size of tires are differences between the two Especially, the subject device is convertible either 24 or 12 inches of devices. the rear wheels. The overall appearance differences are not safety aspect.
The weight limit of the predicate device is 100kgs/2201bs and the subject device is 250lb. The seat heights between the new device and the predicate device have small difference, not leading to any safety hazard. The hanger and rear axle designs are The caster sizes are same. The weight of the new device is heavier and the same. user can feel more stable to transport it. At last the optional accessories for the two devices are same, and the users have the same status to choose the needed accessories to accommodate their needs.
Thus the new device is substantially equivalent to the predicate devices in this aspect.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 8 2006
Well Home Health Products Co. c/o Dr. Ke-Min Jen No. 58 Fu-Chiun Street Hsin-Chu City, China (Taiwan)
Re: K060251
Trade/Device Name: WH Convertible Lightweight Wheelchair, Model WHL, 100 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: February 13, 2006 Received: February 21, 2006
Dear Dr. Jen:
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 cnactment 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 cither 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 (11 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. 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.
3
Page 2 - Dr. Jen
ff 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,
Hulut Leen to
/ Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for Well Home Health Products Co. The logo consists of the letters W.H.H. in a bold, stylized font on the left side of the image. To the right of the letters is the company name, "Well Home Health Products Co," written in a smaller, less bold font. There are also some Chinese characters below the company name.
89 Yongkare Judi St Dali City Taiching County 41.1 Tarwan (R (0 ( 1 - 1 - 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Indications for Use
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
and the control of the country of the county of the county of
Device Name: WH Convertible Lightweight Wheelchair, WHL 100
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
oncurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off)
Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K060251