MULTI FRAME WHEELCHAIR

K100084 · R82 A/S · IOR · Apr 12, 2010 · Physical Medicine

Device Facts

• Record ID: K100084
• Device Name: MULTI FRAME WHEELCHAIR
• Applicant: R82 A/S
• Product Code: IOR · Physical Medicine
• Decision Date: Apr 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The Multi Frame's intended function and use is provide mobility to children limited to a sitting position. The Wheelchair consists primarily of an aluminum frame, large rear wheels with hand rims for propelling the wheelchair or smaller rear wheels for attendant-only use, and smaller front privoting casters for steering and turning.

Device Story

Multi Frame Wheelchair provides mobility for children restricted to sitting. Device comprises aluminum frame, rear wheels (hand-rim propelled or attendant-only), and front pivoting casters for steering. Operated by child or attendant in clinical or home settings. Mechanical design facilitates patient transport and positioning.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Aluminum frame construction; mechanical propulsion via hand rims or attendant-assisted; front pivoting casters for steering. Class I device.

Indications for Use

Indicated for children limited to a sitting position requiring mobility assistance.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

## APR 1 2 2010

R82 A/S % Snug Seat, Inc. President Mr. Kirk MacKenzie P.O. Box 1739 Matthews, North Carolina 28106

Re: K100084

Trade/Device Name: Multi Frame Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: December 15, 2009 Received: January 12, 2010

Dear Mr. MacKenzie:

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. Kirk MacKenzie

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.

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/CDRH0ffices/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely vours

cerely yours,

For

N. Mellow

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): K100084 Device Name: Multi Frame Wheelchair Indications For Use: The Multi Frame's intended function and use is provide mobility to children limited to a sitting position. The Wheelchair consists primarily of an aluminum frame, large rear wheels with hand rims for propelling the wheelchair or smaller rear wheels for attendant-only use, and smaller front privoting casters for steering and turning. ····Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDF leyice Evaluation (ODE)

> (Division Sign-Off (Division Sign=QIC). Orthopedio.
> Division of Surgices Division of Bargerive Devices

510(k) Number K00084

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