(54 days)
Not Found
No
The description focuses on the mechanical design and materials of a wheelchair for aquatic use, with no mention of AI or ML capabilities.
No
The device is a wheelchair designed for mobility and transferring individuals into a swimming pool; it does not treat or alleviate any medical condition.
No
The device is a wheelchair designed for mobility and transferring individuals into a swimming pool, not for diagnosing medical conditions.
No
The device description clearly outlines a physical wheelchair with a rigid frame, wheels, casters, and a seat, all made of physical materials like stainless steel and plastic. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to non-ambulatory persons and assist with transferring them into a swimming pool. This is a physical function, not a diagnostic one.
- Device Description: The description focuses on the physical construction and features of a wheelchair designed for aquatic use. There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
- Lack of IVD Characteristics: The document explicitly states "Not Found" for mentions of image processing, AI/DNN/ML, input imaging modality, anatomical site, patient age range, training/test sets, performance studies, and key metrics. These are all common elements associated with IVD devices.
- Predicate Device: The predicate device is a "Stainless Steel Aquatic Wheelchair," which is also a mobility aid, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This wheelchair does not perform any such function.
N/A
Intended Use / Indications for Use
This wheelchair provides mobility to non-ambulatory persons. The device is used primarily for transferring individuals into a swimming pool via a ramp. This device is designed to wheel chair for this into a swimming pool via a ra.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The MAC-Mobile Aquatic Chair features a rigid frame design and is suitable to provide mobility both indoors and in wet conditions. Primarily designed to assist non-ambulatory users to gain entry to a swimming pool via a ramp, the Aquatic Wheelchair features anti-tip wheels that are built into the design.
The MAC-Mobile Aquatic Chair is fabricated from stainless steel that is coated with a tough powder coated finish. The wheels and casters are made from a water friendly plastic material. The rigid plastic seat is specifically designed for use in an aquatic environment. The entire product can be submersed into pool water with no harmful effects.
The User's Manual provides information on warnings, maintenance, and operating instructions.
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)
Not Found
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
JUN 2 3 2010
RehaMed International, LLC 522 West Mowry Drive Homestead, FL 33030
305-586-7779
510(k) Summary Prepared 4/28/10
| Submitted By | RehaMed International. LLC
522 West Mowry Drive
Homestead, FL 33030
Phone: 305-586-7779 |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | John Caden
President
144 Severino Drive
Islamorada, FL 33036
Phone: 305-586-7779
eMail: johnjcaden@gmail.com |
| Trade Name of Device | MAC-Mobile Aquatic Chair |
| Common Name of Device | Wheelchair, Mechanical |
| Proposed Classification of
New Device | Class 1
21 CFR section 890.3850
Wheelchair, Mechanical |
| Panel | Physical Medicine
Prosthetic Devices
Subpart D 890 |
| Product Code | IOR |
| Existing Classification of
Predicate Device | Class 1
21 CFR section 890.3850
Wheelchair, Mechanical |
| Legally Marketed Predicate
Device for Claimed
Equivalence | Stainless Steel Aquatic Wheelchair
Marketed by D.B. Perks & Associates
Under 510(k) K031910
Granted July 25, 2003 |
| Intended Use of the Device | This wheelchair provides mobility to non-
ambulatory persons. The device is used
primarily for transferring into a swimming pool
via a ramp |
| Target Populations | Any non-ambulatory person who wishes to
gain access to a swimming pool via a ramp. |
| Device Comparison | The device is substantially equivalent to the
predicate device listed above. Both products
have the same technological characteristics
and indications for use. Both products are
designed to be used in a swimming pool
environment. |
| | Appendix 1 contains product information of the
predicate device. |
| Device Description | The MAC-Mobile Aquatic Chair features a rigid
frame design and is suitable to provide mobility
both indoors and in wet conditions. Primarily
designed to assist non-ambulatory users to
gain entry to a swimming pool via a ramp, the
Aquatic Wheelchair features anti-tip wheels
that are built into the design. |
| | The MAC-Mobile Aquatic Chair is fabricated
from stainless steel that is coated with a tough
powder coated finish. The wheels and casters
are made from a water friendly plastic material.
The rigid plastic seat is specifically designed
for use in an aquatic environment. The entire
product can be submersed into pool water with
no harmful effects. |
| | The User's Manual provides information on
warnings, maintenance, and operating
instructions. |
| | Photographs of the product are contained in
Appendix 2 |
Image /page/0/Picture/6 description: The image shows a logo with the letters 'RMT' in bold, black font. The letters are stacked vertically, with 'R' on top, 'M' in the middle, and 'T' at the bottom. A thick, black line is drawn above the letters. Behind the letters is a faded image of a globe, with lines encircling it, suggesting a global or international context. The overall design appears to represent a company or organization with a global reach, possibly in the fields of research, management, or technology.
1
:
.
·
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract image of an eagle with outstretched wings, symbolizing freedom and the pursuit of health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
RehaMed International, LLS % Mr. John Caden President 522 West Mowry Drive Homestead, Florida 33030
JUN 2 3 2010
Re: K101217
Trade/Device Name: MAC-Mobile Aquatic Chair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: 1 Product Code: IOR Dated: April 28, 2010 Received: April 30, 2010
Dear Mr. Caden:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. John Caden
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark A. Mikkelsen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K101217 Device Name: MAC-Mobile Aquatic Chair Indications For Use:
This wheelchair provides mobility to non-ambulatory persons. The device is used primarily for transthe the only pronues moonly to hon-ambulatory persons. This device is used primarily for trans.
fering individuals into a swimming pool via a ramp. This device is designed to wheel chair for this into a swimming pool via a ra
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ X (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)
(Division Sign-C Diff Division of Surgical, Ormopedic, and Restorative Devices
510(k) Number K101217
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