(15 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
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.
The acceptance criteria pertain to the JAN MAO Wheelchair models JMC612-FL318EPP and JMC612-FL418EPP.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC Vol. 1 | Meets applicable performance requirements |
| ISO 7176 Wheelchair Standards | Meets applicable performance requirements |
| California Technical Bulletin CAL 117 (flame retardant for upholstery) | Meets standard for flame retardant |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific "test set" sample size or data provenance in terms of country of origin or whether it was retrospective or prospective. It refers to general "Performance Testing" against standards. This suggests that the testing was likely done on physical samples of the manufactured wheelchairs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" for a medical device like a wheelchair is established by its adherence to recognized engineering and safety standards (ANSI/RESNA WC Vol. 1, ISO 7176, CAL 117), not by expert consensus on clinical presentation or pathology.
4. Adjudication Method for the Test Set:
Not applicable. The evaluation relies on standardized testing protocols outlined in the referenced standards, not an adjudication process involving human reviewers for clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a diagnostic device where human reader performance would be enhanced by AI. The device is a mechanical wheelchair.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The device is a mechanical wheelchair, not an algorithm. Performance testing is purely standalone, meaning the device itself is tested against established engineering and safety benchmarks.
7. Type of Ground Truth Used:
The ground truth used for performance evaluation is based on recognized engineering and safety standards. Specifically:
- ANSI/RESNA WC Vol. 1 (Wheelchair standards for performance requirements)
- ISO 7176 Wheelchair Standards (International standards for wheelchairs)
- California Technical Bulletin CAL 117 (Standard for flame retardancy of upholstery fabric)
8. Sample Size for the Training Set:
Not applicable. The JAN MAO Wheelchair is a mechanical device, not an AI/ML algorithm or software that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
Study Proving Device Meets Acceptance Criteria:
The document states that "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." Additionally, the upholstery fabric "meets the California Technical Bulletin CAL 117 standard for flame retardant."
This indicates that internal performance testing, likely conducted by the manufacturer or a third-party testing facility, was performed to verify compliance with these established standards. While the specific test reports are not included in this summary, the statement serves as the manufacturer's claim of compliance based on such studies. The FDA's 510(k) clearance implies that the FDA found sufficient evidence in the submission to support these claims, allowing the device to be marketed as substantially equivalent to a predicate device that also meets these standards.
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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 )
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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.
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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.
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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
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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
Page 1 of 1
510(k) Number K062218
§ 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).