(21 days)
Invacare Top End Terminator SS, Sunrise Medical Quickie Suspension Wheelchair Series Model XTR, Colours Boing
Not Found
No
The summary describes a mechanical wheelchair with no mention of AI or ML components or functions.
No.
The device description indicates it is a self-propelled, rigid frame, mechanical wheelchair intended to provide mobility, but does not mention any therapeutic claims or functions beyond providing mobility.
No
This device is a wheelchair designed to provide mobility, not to diagnose medical conditions or diseases. Its description focuses on mechanical function and user mobility rather than detection or analysis of health states.
No
The device description clearly states it is a "self-propelled, rigid frame, mechanical wheelchair consisting of components typical of most manual wheelchairs," indicating it is a physical hardware device.
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 detect diseases, conditions, or infections.
- Shockwave Suspension Wheelchair Function: The description clearly states the device's purpose is to provide mobility to individuals with physical limitations. It is a mechanical device used for transportation and support, not for analyzing biological samples.
The information provided about the device's intended use, description, and lack of mentions of biological samples, testing, or analysis confirms it is not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the Shockwave Suspension Wheelchair is to provide mobility to persons with physical limitations limited to a sitting position.
Product codes
IOR
Device Description
Shockwave Suspension Wheelchair is a self-propelled, rigid frame, mechanical wheelchair consisting of components typical of most manual wheelchairs. It has large rear wheels with push rims for self-propulsion and small front pivoting casters for turning and stability. It is a lightweight, user adaptable, everyday chair for use both indoors and outdoors.
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
all as; s
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Invacare Top End Terminator SS, Sunrise Medical Quickie Suspension Wheelchair Series Model XTR, Colours Boing
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
(022/23
510(K) Summary
Submitter
Per4maX Medical, LLC 2550 114" Street Suite 190 Grand Prairie, Texas 75050 Phone: (972) 641-6773 Fax: (972) 623-0585
Tim Criswell
Date
June 20,2003
Name of Device
Shockwave Suspension Wheelchair
Predicate Devices
Invacare Top End Terminator SS Sunrise Medical Quickie Suspension Wheelchair Series Model XTR Colours Boing
Description of Device
Shockwave Suspension Wheelchair is a self-propelled, rigid frame, mechanical wheelchair consisting of components typical of most manual wheelchairs. It has large rear wheels with push rims for self-propulsion and small front pivoting casters for turning and stability. It is a lightweight, user adaptable, everyday chair for use both indoors and outdoors.
Intended Use
The intended use of Shockwave Suspension Wheelchair is to provide mobility to persons with physical limitations limited to a sitting position.
Substantial Equivalence
The Per4maX Shockwave Wheelchair is substantially equivalent to the listed predicate devices in its specifications, performance and use.
1
Image /page/1/Picture/1 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 image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Per4maX Medical. LLC % Mr. Tim Criswell 2550 114th Street, Suite 190 Grand Prairie, Texas 75050
Re: K032123
Trade Name: Shockwave Suspension Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Names: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: June 20, 2003 Received: July 10, 2003
Dear Mr. Tim Criswell:
This letter corrects our substantially equivalent letter of July 31, 2003.
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. Iisting 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.
MAR 2 4 2009
2
Page 2 - Mr. Tim Criswell
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K 032123
Interlied I se Device
The intended use of the Shockwave Su:pension Wheelchair is to provide mobility to persons with physical limitations limited to a sitting position. It is intended for indoors and outdoor use by individuals of all as; s who are physically challenged.
Mark A. Milken
(Division Sign-Off) Division of General, Restorative and Neurological Devices K032123
510(k) Number .
网