(14 days)
Chunc pediatic attendant controlled wheelchair is intended for clients with moderate to specialists. The controlled by the for the last controlled needs first and foremost. Chunc pediatic attendant controlled wheeledall 15 michood attendents needs first and foremost.
Chunc manual wheelchairs empower physically challenged persons by providing a means of ten and and contract and annonemant conditions swch as: Chunc manual whicheman's chiponery and permanent conditions such as: Arthritis, Amputee, Paraplegia, Muscular Dystrophy, Tetraplegia, Quadriplegia, Spina Bifida, and any other immobilizing or debilitating condition, Multiple Sclerosis, Polio, Cerebral Palsy.
The modular design of the wheelchair chassis, frame and seating allows for flexibility and ease of The modular design of the wheelchard and social needs. This coupled with material choice and the frequent use of like parts across the when associated us to keep costs at a numming the frequent use of like parts actoss to be easily identifies a for any increase tunctions using unified adjustments with color coding which are also simple to see and maintain. By moving away from the cumbersome welded steel structures of conventional wheelchairs we have been away from the cumbersome welcen steer surverling of envired to envire the wheelchair is lightweight and therefore comfortable to use. Chunc is carrently manifactured and marketed the lightweight and therefore comical by the National Health Service (NHS) and has the relevant CES marking. Chunc also provides the ability for Bus Transportation and notest that meet the marking. Chunc also provides the ability to: Dos Transportation and occupants (WTORS) that meet the requirements of SAE J2249
The provided document is a 510(k) clearance letter from the FDA for two wheelchair models (Chunc Junior Model# Sm 242, Chunc Adapt Model # Sm 251). This type of document does not contain acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) clearance process is based on demonstrating substantial equivalence to a predicate device, not necessarily on performance against specific acceptance criteria derived from a clinical study. It primarily focuses on the device's intended use, technological characteristics, and safety and effectiveness compared to an already legally marketed device.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies) from this document. This information is typically found in design validation reports or clinical study summaries, which are not part of the 510(k) clearance letter itself.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 8 2004
Mr. Steve Gibson Specmat Technologies, Inc. 215 Dunavant Drive Rockford, Tennessee 37853
Re: K042304
K04250+
Trade/Device Name: Chunc Junior Model# Sm 242, Chunc Adapt Model # Sm 251 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: August 24, 2004 Received: August 25, 2004
Dear Mr. Gibson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications forchered above and have sure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimetee prior to may 20, 2017 3)
devices that have been reclassified in accordance with the provisions of the Federal Food, DNA A de rices may been receases at require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, merelere, maxis 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 may be subject to back academans, 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 that I Dr has intatutes and regulations administered by other Federal agencies. You must or any I outher 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 Orth 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 – Mr. Steve Gibson
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yourse FDA finding of substantial equivalence of your device to a legally premailed predicated with 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 If you desire specific as not as (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 other general mionnation of Jour Copsumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Williams
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
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510(k) Number (if known): K042304
Device Name: Chunc Junior Model# Sm 242, Chunc Adapt Model # Sm 251
Indications For Use:
Chunc pediatic attendant controlled wheelchair is intended for clients with moderate to specialists.
The controlled by the for the last controlled needs first and foremost. Chunc pediatic attendant controlled wheeledall 15 michood attendents needs first and foremost.
Chunc manual wheelchairs empower physically challenged persons by providing a means of
ten and and contract and annonemant conditions swch as: Chunc manual whicheman's chiponery and permanent conditions such as:
| Arthritis | Tetraplegic | Multiple Sclerosis |
|---|---|---|
| Amputee | Quadriplegic | Polio |
| Paraplegic | Spina Bifida | Cerebral Palsy |
| Muscular Dystrophy | and any other immobilizing or debilitating condition |
The modular design of the wheelchair chassis, frame and seating allows for flexibility and ease of The modular design of the wheelchard and social needs. This coupled with material choice and the frequent use of like parts across the when associated us to keep costs at a numming the frequent use of like parts actoss to be easily identifies a for any increase tunctions using unified adjustments with color coding which are also simple to see and maintain. By moving away from the cumbersome welded steel structures of conventional wheelchairs we have been away from the cumbersome welcen steer surverling of envired to envire the wheelchair is lightweight and therefore comfortable to use. Chunc is carrently manifactured and marketed the lightweight and therefore comical by the National Health Service (NHS) and has the relevant CES marking. Chunc also provides the ability for Bus Transportation and notest that meet the marking. Chunc also provides the ability to: Dos Transportation and occupants (WTORS) that meet the requirements of SAE J2249
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (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)
Mark N. Millerson
Division of General, Restorative, and Neurological Devices
Page 1 of _
10(k) Number K042304
510(k) Number.
§ 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).