(26 days)
Not Found
No
The summary describes a standard mechanical wheelchair with no mention of AI or ML features.
No
The device is a wheelchair, which provides mobility support, but it does not treat or cure a medical condition.
No
The device description states its purpose is to provide mobility, and there is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly describes a physical wheelchair with a base, wheels, and seat, 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 aid, not a diagnostic test performed on samples 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 the body
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The information provided describes a standard medical device for mobility, 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 restricted to a seated position.
Product codes
IOR
Device Description
The JAN MAO Wheelchair, JMC612-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.
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-F18EPP 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 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
K051482 JUN 2 9 2005 1/2
JMe
ISO 9000
進貿實業有限公司
JAN MAO INDUSTRIES CO., LTD.
1F. No. 22 Alley 20 Lanc142. Sec. 6. Roosevelt Rd..
Wen-Shar Dist., Taiper. Taiwan, R. O. C.
TEL: 886-2-2930-0381 FAX: 886-2-2931-2455
E-mail Address: Jewe88@m27.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:
Proprietary Name:
Common or Usual Name: Classification Name:
May 27, 2005
JAN MAO. Wheelchair, JMC612-F18EPP 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-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, JMC612-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 )
1
Me 進貿實業有限公司
JAN MAO INDUSTRIES CO., LTD.
ISO 9002
- No. 22. Alley 20 Lane142. Sec. 6. Roosevelt Rd.
Wen-Soar Dist., Taipei, Taiwan. R. O. C.
TEL: 886-2-2930-0381 FAX: 886-2-2933-3455
E-mail Address: jewel88@ms27.hinet.net
2/2
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. Besides, the predicate device is fixed frame and the new device is removable desk-length armrest and swing-away detachable elevating footrest. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate device.
2
Image /page/2/Picture/13 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines above two wavy lines.
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: K051482
Trade/Device Name: JAN MAO, Wheelchair JMC612-F18EPP Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: May 27, 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.
3
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,
Stupt Charles
iam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510 (K) Number ( If Known ): K
Device Name: JAN MAO, Wheelchair JMC612-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)
Hyet Murda
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative. and Neurological Devices
Page 1 of 1
510(k) Number K051482