(20 days)
Not Found
No
The description focuses on the mechanical aspects and standards compliance of a wheelchair, with no mention of AI or ML.
No
The device provides mobility support rather than treating a medical condition or restoring a bodily function.
No
The device is described as a wheelchair intended for mobility, not for diagnosing medical conditions.
No
The device description clearly states it is 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 clearly states the device is for 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, 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.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a medical device, specifically a wheelchair, but it falls 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 WH Convertible Lightweight Wheelchair MC-281S and MC-200S 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. Back upholstery material is also the same resistance-ignitability fabric.
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)
MC-281S and MC-200S are Foldable Wheelchair meet 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): 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
MANUFACTURING MEDCARE
No.351, Chungcheng Rd., Sec. 2, Changhua, 500, Taiwan, R.O.C. FAX:886-4-7220077 TEL:886-4-7249349 E-mail:ceirs.jen@msa.hinet.net http://www.fmh.com.tw/medcare
66 510(k) SUMMARY " JUL - 5 2006
Submitter's Name: MEDCARE MANUFACTURING INC. No.351, Chungcheng Rd., Sec. 2, Changhua, 50041, Taiwan, R.O.C.
Date summary prepared: Device Name:
June 10, 2006
Proprietary Name: MEDCARE Mechanical Wheelchair, MC-281S and MC-200S Common or Usual Name: Mechanical Wheelchair Classification Name: 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 WH Convertible Lightweight Wheelchair MC-281S and MC-200S 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. Back upholstery material is also the same resistance-ignitability fabric.
Performance Testing:
MC-281S and MC-200S are Foldable Wheelchair meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
Legally marketed device for substantial equivalence comparison: WH Convertible Lightweight Wheelchair, WHL100 ( K060251 )
1
MEDCARE MANUFACTURING INC.
No.351, Chungcheng Rd., Sec. 2, Changhua, 500, Taiwan, R.O.C. TEL:886-4-7249349 FAX:886-4-7220077 E-mail:ceirs.jen@msa.hinet.net http://www.finh.com.tw/medcare
Summary for substantial equivalence comparison:
Caller and Roman Child States Missamming
Research Production Pro March 11 11 11 11 11 11
The intended use of the two devices is the same, and mainframes of two devices are the same foldable. The overall dimensions are similar. Back upholstery material is also the same resistance -ignitability fabric. The major differences existing are the overall dimension, and the size of tires are differences between the two devices. Especially, the subject device MC-281S has the head cushion. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.
The weight limit of the subject device is 100 kgs / 220 lbs and the predicate device is 250 lbs. The seat heights between the new device and the predicate device have small difference, not leading to any safety hazard. The hanger and rear axle designs The weight of the new device is heavier and the user can feel more are same, stable to transport it. At last the optional accessories for the two devices are same and the users have the same status to choose the needed accessories to accommodate their needs.
Thus the new device is substantially equivalent to the predicate devices in this aspect.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The caduceus is surrounded by the words "U.S. Department of Health and Human Services" in a circular arrangement. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDCARE MANUFACTURING INC. % ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY Dr. Ke-Min Jen No. 58 Fu-Chiun St. JUL - 5 2006 Hsin-Chu City China (Taiwan) 30067
Re: K061694
Trade/Device Name: MEDCARE Mechanical Wheelchair, MC 281S, MC-200S Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulation Class: I Product Code: IOR Dated: June 10, 2006 Received: June 15, 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.
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
3
Page 2 - Dr. Jen
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/cdr/industry/support/index.html (
Sincerely yours,
Barbaje Buclus
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
MANUFACTURING INC. MEDCARE
No.351, Chungcheng Rd., Sec. 2, Changhua, 500, Taiwan, R.O.C. TEL:886-4-7249349 FAX:886-4-7220077 E-mail:ceirs.jen(@msa.hinet.net http://www.fmh.com.tw/medcare
Indications for Use
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: MEDCARE Mechanical Wheelchair, MC-281S, MC-200S
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)
510(k) Numbe
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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