TRANSPORT SERIES TRANSPORT CHAIR

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Access Point Medical. The logo consists of a stylized image of a circle with a triangle inside of it, and the words "ACCESS POINT" in large letters, with the word "MEDICAL" in smaller letters underneath. The image also contains the date "APR 1 1 2005" in the upper right corner. K050281 1/2 ## 3. SUMMARY OF SAFETY AND EFFECTIVENESS ## SPONSOR IDENTIFICATION A. Mr. Patrick Richey Access Point Medical, L.L.C. 10 Glenville Street Greenwich, CT 06831 #### B. ESTABLISHMENT REGISTRATION NUMBER: Pending ## C. OFFICIAL CONTACT PERSON Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, MD 20854 estrin@yourFDAconsultant.com Tel: (301) 279 -2899 Fax: (301) 294-0126 ## D. DATE OF PREPARATION OF THIS SUMMARY: February 4, 2005 - PROPRIETARY (TRADE) NAME: AXS Transport Chair E. - COMMON NAME: F. Wheelchair - CLASSIFICATION NAME: Wheelchair, mechanical G. - H. REGULATION NUMBER: 21 CFR 890.3850 - I. PROPOSED REGULATORY CLASS: Class 1 - DEVICE PRODUCT CODE: IOR J. - MEDICAL SPECIALTY: K. Physical Medicine - L. DESCRIPTION OF DEVICE The Access Point Medical AXS Transport Chair is a wheelchair that 0010 10 Glenville Street, Greenwich, Ct 06831 USA Where well-being and accessibility meet. {1}------------------------------------------------ K050281 2/2 provides mobility to persons limited to a sitting position. It consists of a rigid mechanical Aluminum Alloy or steel frame and nylon upholstery that meets EN102-1: Assessment of the Ignitability of Upholstered Furniture. It has two 8x1" solid rubber rear wheels and two 8x1" front casters for turning and maneuverability. The Access Point Medical Transport Series Transport Chair is intended for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater that 9 degrees. #### M. INDICATIONS FOR USE: The AXS Transport Chair is indicated for providing mobility to persons limited to a sitting position #### N. PREDICATE DEVICE Jiangsu Intco Medical Equipment & Supply Co., Ltd. EZ-Comfort Transporter 2000 series (K002673). #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: 0. The AXS Transport Chair and the Jiangsu Intco Medical Equipment & Supply Co., Ltd. EZ- Comfort Transporter 2000 series (K002673) are identical products made by the same manufacturer to the same specifications. #### TECHNOLOGICAL CHARACTERISTICS SUMMARY: P. The standards used for Access Point Medical wheelchair production meet the following standards: ISO 7171-1 Wheelchair: Determination of static stability Wheelchair: Determination of efficiency of brakes ISO 7176-3 Wheelchair: Requirements and test methods for static, impact and ISO 7176-8 fatigue strengths ISO 7176-11 Wheelchair: Test dummies ISO 7176-15 Wheelchair: Requirements for information disclosure, documentation and labeling. ISO 7176-16 Wheelchair: Resistance of ignition of upholstered parts -Requirements and test methods Furniture - Assessment of the Ignitability of Upholstered Furniture EN 1021-1 # Q. CONCLUSION Access Point Medical AXS Transport Chair conforms fully to the standards which are mentioned in Section P as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims required by these standards. There are no safety/efficiency issues or claims that differ from the predicate devices cited. 0011 {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol, with three curved lines forming the body and wings. APR 1 ] 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Dr. Norman F. Estrin Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854 Re: K050281 Trade/Device Name: AXS Transport Chair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 24, 2005 Received: March 24, 2005 Dear Dr. Estrin: 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. {3}------------------------------------------------ # Page 2 - Dr. Norman F. Estrin Ph.D., RAC 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 Office of Compliance at (240) 276-0120 . 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Hupt Clurds Mirian C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use Page 1 of 1 510(k) Number (if known): __K050281___________________________________________________________________________________________________________________________________________ Device Name: AXS Transport Chair______________________________________________________________________________________________________________________________________________ - 1. Indications for Use: AXS Transport Chairs are indicated for providing mobility to persons limited to a sitting position | Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use X<br>(21 CFR 801 Subpart C) | |-------------------------------------------------|--------|--------------------------------------------------| |-------------------------------------------------|--------|--------------------------------------------------| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices | 510(k) Number | K050281 | |---------------|---------| |---------------|---------| 0009