MAC-MOBILE AQUATIC CHAIR

K101217 · Rehamed Intl., LLC · IOR · Jun 23, 2010 · Physical Medicine

Device Facts

• Record ID: K101217
• Device Name: MAC-MOBILE AQUATIC CHAIR
• Applicant: Rehamed Intl., LLC
• Product Code: IOR · Physical Medicine
• Decision Date: Jun 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

This wheelchair provides mobility to non-ambulatory persons. The device is used primarily for transferring into a swimming pool via a ramp.

Device Story

Mechanical wheelchair; rigid stainless steel frame with powder-coated finish; water-friendly plastic wheels/casters; rigid plastic seat. Designed for mobility in indoor and wet environments; enables non-ambulatory users to enter swimming pools via ramps. Features integrated anti-tip wheels. Fully submersible in pool water. Operated by user or caregiver; manual propulsion. Provides mobility and pool access; facilitates aquatic therapy or recreation.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Stainless steel frame with powder-coated finish; water-friendly plastic wheels and casters; rigid plastic seat. Manual operation; no energy source. Submersible design.

Indications for Use

Indicated for non-ambulatory persons requiring mobility assistance to access swimming pools via ramps.

Regulatory Classification

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.

Predicate Devices

• Stainless Steel Aquatic Wheelchair (K031910)

Submission Summary (Full Text)

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K101217

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<br>522 West Mowry Drive<br>Homestead, FL 33030<br>Phone: [phone] |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | John Caden<br>President<br>144 Severino Drive<br>Islamorada, FL 33036<br>Phone: [phone]<br>eMail: [e-mail] |
| Trade Name of Device | MAC-Mobile Aquatic Chair |
| Common Name of Device | Wheelchair, Mechanical |
| Proposed Classification of<br>New Device | Class 1<br>21 CFR section 890.3850<br>Wheelchair, Mechanical |
| Panel | Physical Medicine<br>Prosthetic Devices<br>Subpart D 890 |
| Product Code | IOR |
| Existing Classification of<br>Predicate Device | Class 1<br>21 CFR section 890.3850<br>Wheelchair, Mechanical |
| Legally Marketed Predicate<br>Device for Claimed<br>Equivalence | Stainless Steel Aquatic Wheelchair<br>Marketed by D.B. Perks & Associates<br>Under 510(k) K031910<br>Granted July 25, 2003 |
| Intended Use of the Device | This wheelchair provides mobility to non-<br>ambulatory persons. The device is used<br>primarily for transferring into a swimming pool<br>via a ramp |
| Target Populations | Any non-ambulatory person who wishes to<br>gain access to a swimming pool via a ramp. |
| Device Comparison | The device is substantially equivalent to the<br>predicate device listed above. Both products<br>have the same technological characteristics<br>and indications for use. Both products are<br>designed to be used in a swimming pool<br>environment. |
| | Appendix 1 contains product information of the<br>predicate device. |
| Device Description | The MAC-Mobile Aquatic Chair features a rigid<br>frame design and is suitable to provide mobility<br>both indoors and in wet conditions. Primarily<br>designed to assist non-ambulatory users to<br>gain entry to a swimming pool via a ramp, the<br>Aquatic Wheelchair features anti-tip wheels<br>that are built into the design. |
| | The MAC-Mobile Aquatic Chair is fabricated<br>from stainless steel that is coated with a tough<br>powder coated finish. The wheels and casters<br>are made from a water friendly plastic material.<br>The rigid plastic seat is specifically designed<br>for use in an aquatic environment. The entire<br>product can be submersed into pool water with<br>no harmful effects. |
| | The User's Manual provides information on<br>warnings, maintenance, and operating<br>instructions. |
| | Photographs of the product are contained in<br>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.

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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

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## 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 [phone] or [phone] 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

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## 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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