(28 days)
Not Found
No
The device description and performance studies indicate a purely mechanical, manually operated wheelchair with no mention of AI or ML components.
No.
The device is a manual wheelchair, intended for mobility, not for treating or diagnosing a medical condition.
No
Explanation: The device is a manual wheelchair, described as providing mobility to persons limited to a sitting position. Its function is to transport and support, not to diagnose medical conditions or analyze bodily functions.
No
The device description explicitly details physical components like a metal frame, wheels, and casters, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is a "Manual Wheelchair Series" used to "provide mobility to persons limited to a sitting position." It describes a physical, mechanical device for transportation and mobility.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids or tissues, or any diagnostic function related to a person's health status based on in vitro analysis.
The device is a mobility aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The intended use of the Manual Wheelchair Series is to provide mobility to persons limited to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The Manual Wheelchair Series are manually operated, self or attendant propelled, manual, mechanical wheelchairs. Their intended function and use is to provide mobility to persons limited to a sitting position. The products may also be used as attendant propelled patient transport devices in a health care environment such as hospital, nursing homes, or extended care facilities.
The products consist primarily of a metal frame, large rear wheels with hand rims for propelling the chair, and smaller front pivoting casters for steering and turning. There is also an attendant propelled version (Model 0400), which has smaller rear wheels than the others in the series.
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)
The Manual Wheelchair Series meet the applicable requirements specified in part 8 of the ISO Standard ISO 7176: 1993(E), "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs
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
510(k) SUMMARY
Shanghai Wheelchair Factory's Manual Wheelchair Series
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Shanghai Wheelchair Factory 80 Lane 251 Zoayang Road Shanghai, China 200062 Phone: 86-21-62542392 Fax:86-21-62168882
Contact Person:
Tracy Ma Representing Shanghai Wheelchair Factory Project Manager Vendor Development Group, Inc. 120 Ionia Street SW Grand Rapids, MI 49503
Date Prepared:
February 28, 2004
Name of Device and Name/Address of Sponsor
Manual Wheelchair Series
Vendor Development Group, Inc. 120 Ionia Street SW Grand Rapids, MI 49503 Phone: (8770 836-3673 Fax: (616) 459-9850
Common or Usual Name
Manual Wheelchair
Classification Name
Wheelchair, Mechanical
1
Predicate Devices
The Shanghai Series Manual Wheelchairs are substantially equivalent to are Invacare's Model "Action Patriot" Manual Wheelchair (K930803) and Sunrise Medical's Model "Breezy 510" Manual Wheelchair (K974820)
Intended Use
The intended use of the Manual Wheelchair Series is to provide mobility to persons limited to a sitting position.
Technological Characteristics and Substantial Equivalence
A. Device Description
The Manual Wheelchair Series are manually operated, self or attendant propelled, manual, mechanical wheelchairs. Their intended function and use is to provide mobility to persons limited to a sitting position. The products may also be used as attendant propelled patient transport devices in a health care environment such as hospital, nursing homes, or extended care facilities.
The products consist primarily of a metal frame, large rear wheels with hand rims for propelling the chair, and smaller front pivoting casters for steering and turning. There is also an attendant propelled version (Model 0400), which has smaller rear wheels than the others in the series.
B. Substantial Equivalence
The Shanghai Series Manual Wheelchairs are substantially equivalent to Invacare's Model "Action Patriot" Manual Wheelchair (K930803) and Sunrise Medical' s Model "Breezy 510" Manual Wheelchair (K974820)
PERFORMANCE DATA
The Manual Wheelchair Series meet the applicable requirements specified in part 8 of the ISO Standard ISO 7176: 1993(E), "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2004
Shanghai Wheelchair Factory C/o Ms. Tracy Ma Project Manager Vendor Development Group, Inc. 120 Ionia Street SW Grand Rapids, Michigan 49503
Re: K040561
Trade/Device Name: Manual Wheelchair Series Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: January 29, 2004 Received: March 5, 2004
Dear Ms. Ma:
This letter corrects our substantially equivalent letter of March 31, 2004 regarding the device named above. The Trade/Device Name was incorrectly listed as Shanghai Series Manual Wheelchairs. The correct Trade/Device Name is listed above.
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 (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 proiltions 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 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.
3
Page 2 - Ms. Tracy Ma
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 continue 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 (301) 594-4659. 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) 632-2011 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain,html
Sincerely vor
sincerely yours,
for Mula N. Mulkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- 510(k) Number (if known): K040561
- Device Name: Manual Wheelchair Series
Indications For Use:
The intended use of Shanghai Wheelchair
Factory's Manual wheelchair series
is to provide mobility to persons.
limited to a sitting position.
(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
510(k) Number K040561
| Labels | Values |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | OR |
| Over-The-Counter Use |
(Optional Format 1-2-96)
APR 05 '04 11:04
301 594 2358
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