(26 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The JAN MAO Wheelchair, JMC611-F18EPP 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.
Here's a breakdown of the acceptance criteria and study information for the JAN MAO Wheelchair, JMC611-F18EPP, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Required by Standard) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC vol. 1 (Wheelchair Standards) | Meets applicable requirements |
| ISO 7176 (Wheelchair Standards) | Meets applicable requirements |
| California Technical Bulletin CAL 117 (Flame Retardant Standard for Upholstery Fabric) | Meets standard |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical data or patient-specific evaluation. The "testing" refers to performance testing of the device itself against established engineering and safety standards.
- No "sample size" of patients or users is mentioned for the performance testing. The wheelchair as a product is tested.
- Data Provenance: The testing was conducted by JAN MAO INDUSTRIES CO., LTD. in Taiwan. The summary does not provide details on specific labs or whether external, independent testing was performed, only that the company states the device "meets the applicable performance requirements."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This type of information is not applicable to the performance testing of a mechanical wheelchair against engineering standards. "Ground truth" in this context refers to the defined specifications within the ANSI/RESNA WC vol. 1 and ISO 7176 standards, and the flame retardancy criteria of CAL 117. These standards are established by technical committees and regulatory bodies, not by individual experts assessing a specific test set.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess a case to establish a consensus ground truth. For equipment performance testing against explicit standards, the results are objectively measured and compared to the standard's specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is a type of clinical trial involving human readers evaluating medical images or data. This is not relevant to the regulatory submission for a mechanical wheelchair, which focuses on device safety and performance according to engineering standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. "Standalone" performance generally refers to the performance of an AI algorithm without human interaction. This concept is not applicable to a mechanical wheelchair.
7. The Type of Ground Truth Used
The "ground truth" used for this device's acceptance is based on:
- Established Industry Standards: ANSI/RESNA WC vol. 1 and ISO 7176 are internationally recognized standards for wheelchair performance and safety.
- Regulatory/Technical Standards: California Technical Bulletin CAL 117 is a specific standard for flame retardancy of materials.
The device's performance is measured against the specifications, test methods, and acceptance criteria defined within these published standards.
8. The Sample Size for the Training Set
N/A. The concept of a "training set" applies to machine learning algorithms. This device is a mechanical wheelchair and does not utilize a training set in this context.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set for a mechanical wheelchair, there is no ground truth established for it in this manner. The "ground truth" for verifying the product is the adherence to the published performance and safety standards.
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Me
150 9002
JUN 2 9 2005
進貿實業有限公司
JAN MAO INDUSTRIES CO., LTD.
IF. No. 22 Alley 20 Lanci42, Sec. 6. Roosevelt Rd,.
Wen-Shan Dist., Taipei, Taiwan. R. O. C.
TEL: 886-2-2930-0381 FAX: 886-2-2931-2455
E-mail Address: Jewel88@ms27.hinet.net
510(k) SUMMARY "
Submitter's Name: JAN MAO INDUSTRIES CO., LTD. No.181, Chu Liao Road, Ta Su Hsiang, Kao Hsiung Hsian, TAIWAN, 840, ROC
Date summary prepared: Device Name:
್ಷಗಳ
Proprietary Name:
Common or Usual Name: Classification Name:
JAN MAO. Wheelchair, JMC611-F18EPP Mechanical Wheelchair Mechanical Wheelchair, Class I, 21 CFR 890.3850
May 26, 2005
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, JMC611-F18EPP 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:
JAN MAO Wheelchair, JMC611-F18EPP 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:
AVANTICARE Mechanical Wheelchair, MR-9000 ( K050708 )
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進貿實業有限公司
JAN MAO INDUSTRIES CO., LTD.
ISO 9002
1F. No. 22. Alley 20 Lane 42, Sec. 6. Roosevelt Rd.,
Wen-Shan Dist., Taipei, Taiwan. R. O. C.
TEL: 886-2-2930-0381 FAX: 886-2-2931-2455
E-mail Address: Jewel88@ms27.hinet.net
Summary for substantial equivalence comparison:
The new device and the predicate device have the same intended use Mainframes of two devices are foldable. The overall dimensions are similar and same weight capacity. Back upholstery material is also the same resistance -ignitability fabric and also meets the California Technical Bulletin CAL 117 standard for flame retardant. The major differences existing are the overall dimension. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate device.
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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight, with stylized wings and tail feathers.
JUN 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jan Mao Industries Company, Ltd. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City, China (Taiwan) 300
Re: K051481
Trade/Device Name: JAN MAO, Wheelchair JMC611-F18EPP Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: May 26, 2005 Received: June 3, 2005
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stypk Rlwarde
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: JAN MAO, Wheelchair JMC611-F18EPP
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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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510(k) Number_ 18 4/1 18 18/1
§ 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).