(15 days)
Not Found
No
The description focuses on the mechanical and structural aspects of a wheelchair and does not mention any AI/ML components or functionalities.
No.
The device is a wheelchair intended for mobility, not for treating a disease or condition.
No
Explanation: The device is a wheelchair intended for mobility, not for diagnosing medical conditions.
No
The device description clearly describes a physical wheelchair with a base, wheels, seat, and upholstery, indicating it is a hardware device, not software-only.
Based on the provided information, 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 from the human body.
- Device Description: The description details a wheelchair, a mechanical device for mobility. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting diseases, conditions, or states of health through in vitro examination.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This wheelchair does not fit that description.
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
IOR
Device Description
The JAN MAO Wheelchair、JMC612-FL318EPP(& JMC612-FL418EPP)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)
JAN MAO Wheelchair, JMC612-FL318EPP ( & JMC612-FL418EPP ) meets the applicable performance 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)
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
Image /page/0/Picture/0 description: The image shows a logo with the letters "JMC" stacked on top of each other. The letters are in a bold, sans-serif font and appear to be slightly distressed or textured. Below the logo, the text "ISO 9002" is printed in a smaller, simpler font. The overall image has a grainy or low-resolution quality.
JAN MAO INDUSTRIES CO., LTD.
1F, NO.2-2, Alley 20, Lane 142, Sec. 6, Roosevelt Road, Taipei, Taiwan, R.O.C. Tel:886-2-2930-0381 Fax: 886-2-2931-2455 E-mail: jewel88@ms27.hinet.net
દ્ધ 510(k) SUMMARY '
AUG 16 2006
Submitter's Name: JAN MAO INDUSTRIES CO., LTD. No.181, Chu Liao Road, Ta Su Hsiang, Kao Hsiung Hsian, TAIWAN, 84045, ROC
Date summary prepared:
July 25, 2006
Device Name:
Proprietary Name:
Classification Name:
JAN MAO, Wheelchair, JMC612-FL318EPP, JMC612-FL418EPP Common or Usual Name: 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 JAN MAO Wheelchair、JMC612-FL318EPP(& JMC612-FL418EPP)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:
JAN MAO Wheelchair, JMC612-FL318EPP ( & JMC612-FL418EPP ) meets the applicable performance 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-F18EPP ( K051482 )
1
Image /page/1/Picture/0 description: The image shows a logo with the letters "JMC" stacked on top of each other. The letters are in a bold, sans-serif font. Below the logo, the text "ISO 9002" is printed in a smaller font. The image has a grainy texture, suggesting it may be a scan or photocopy.
JAN MAO INDUSTRIES CO., LTD. 1F, NO.2-2, Alley 20, Lane 142, Sec. 6, Roosevelt Road, Taipei, Taiwan, R.O.C. Tel:886-2-2930-0381 Fax: 886-2-2931-2455 E-mail: jewel88@ms27.hinet.net
Summary for substantial equivalence comparison:
From the above comparison table the predicate device (JMC612-F18EPP, K051482) and new devices (JMC612-FL318EPP & JMC612-FL418EPP) are the same. JMC612 series products. The intended use between the predicate device and new devices are the same. Mainframes of two devices are foldable. The overall dimensions are similar and the same weight capacity, same 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 Bulletin CAL 117 standard for flame retardant. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2006
JAN MAO INDUSTRIES CO., LTD. % Roc Chinese - European Industrial Dr. Ke-Min Jen No. 58 Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K062218
Trade/Device Name: JAN MAO Wheelchair, JMC612-FL318EPP, JMC612-FK418EPP Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: July 25, 2006 Received: August 1, 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 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.
3
Page 2 - Dr. Ke-Min Jen
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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for Blo Thurnett / ASSAY
Mark N. Melkerson 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 a logo with the letters "JMC" stacked vertically. Below the logo, the text "ISO 9002" is displayed. The logo and text are rendered in black and white, with a slightly grainy or textured appearance.
JAN MAO INDUSTRIES CO., LTD. 1F, NO.2-2, Alley 20, Lane 142, Sec. 6, Roosevelt Road, Taipei, Taiwan, R.O.C. Tel:886-2-2930-0381 Fax: 886-2-2931-2455 E-mail: jewel88@ms27.hinet.net
Indications for Use
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: JAN MAO Wheelchair, JMC612-FL318EPP, JMC612-FL418EPP
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) |
|---|
| -------------------------------------------------------- |
V. Othmer
Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K062218