(81 days)
Not Found
No
The description details a standard manual wheelchair with no mention of AI/ML features or capabilities.
No
The device provides mobility but does not explicitly state it treats or prevents a disease or condition. It serves as an assistive device for mobility.
No
Explanation: The "Intended Use / Indications for Use" section states the device is for providing mobility, which is a therapeutic or assistive function, not a diagnostic one. There is no mention of identifying or detecting 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 aid, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a wheelchair, which is a mechanical device for mobility. It does not mention any components or functions 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 blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in the body.
- Diagnosing diseases or conditions based on biological markers.
This device is a mobility aid, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The KAIYANG Aluminum Wheelchair is 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
Wheelchair the applicable performance KAIYANG Aluminum meets requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
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
§ 890.3850 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
Guangdong Kaiyang Medical Technology Co., Ltd.
Yanfeng Industrial Area, Dali, Nanhai District, Foshan, China, 52823 B
Tel: +86-757-85502506 Fax:+86-757-85502630 Email:ceirs.jen@msa.hinet.net
OCT 4 2010
510(k) SUMMARY "
Submitter's Name: Guangdong Kaiyang Medical Technology Co., Ltd. Yanfeng Industrial Area, Dali, Nanhai District, Foshan, China, 528231
Date summary prepared:
June 21, 2010
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
KAIYANG Aluminum Wheelchair 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 restricted to a seated position.
Description of the device:
The KAIYANG Aluminum Wheelchair is 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:
Wheelchair the applicable performance KAIYANG Aluminum meets requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
Legally marketed device for substantial equivalence comparison:
JAN MAO Wheelchair JMC612-FL318EPP & JMC612-FL418EPP (K062218 )
1
Guangdong Kaiyang Medical Technology Co., Ltd. Yanfeng Industrial Area, Dali, Nanhai District, Foshan, China, 528231 Tel: +86-757-85502506 Fax:+86-757-85502630 Email:ceirs.jen@msa.hinet.net
Summary for substantial equivalence comparison:
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
From the above comparison table the intended use between the predicate device and new devices are the same. Mainframes of two devices are foldable. There are similar removable desk-length armrest and same swing-away detachable elevating footrest. Besides, back upholstery material is also the same resistance-ignitability fabric and also meets the California Technical standard for flame retardant. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate device.
2
Image /page/2/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 coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Guangdong Kaiyang Medical Technology Co., Ltd. % Dr. Ke-Min Jen Official Correspondent Yanfeng Industrial Area, Dali, Nanhai District Foshan China 528231
OCT 4 2000
Re: K101998
Trade/Device Name: KAIYANG Aluminum Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: August 17, 2010 Received: August 25, 2010
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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Dr. Ke-Min Jen
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Mark N. Melin
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: _KAIYANG Aluminum Wheelchair
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
productions and this and world and world be one in the with the with the with the with the with the with the with the with the with the with the with the with the with the wi
Division Sign-Off
(Division Sign. (Division of Surgical, Orthopedic, and Restorative Devices
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number K101998