COMPACT WHEELCHAIR PLATFORM

{0}------------------------------------------------ # design ↓ specific K10/723 DEC 2 3 2010 ### Summary 510(k) Submission ### Compact Wheelchair Platform #### Device name and contacts Device Name 'Compact Wheelchair Platform' Contact Mr. Richard Fletcher Design Specific Ltd Unit 10 Caburn Enterprise Park The Broyle Ringmer East Sussex BN8 SNP Trade Name Common Name Classification Code Compact Wheelchair Platform Wheelchair Reclining Platform 890.3110 Class II Date prepared 21.4.10 R. Fletcher 17.10.07 {1}------------------------------------------------ Compact Wheelchair Platform Trade Name Wheelchair Reclining Platform Common Name Dental Chair and Accessories (CFR 890.3110 Class II) Classification Name Mobile wheelchair Platform Equivalence **Equivalence** Design Specific Ltd K073565 Image /page/1/Picture/3 description: The image contains two separate pictures. The picture on the left shows a chair and a board. The picture on the right shows a person sitting in a chair. #### Description The Compact Wheelchair Platform (CWP) is designed to assist in the clinical treatment of wheelchair users by providing a convenient wheelchair accessible platform that can be tilted so that the head is placed in the optimum position of comfort for both staff and patient. It is a direct development of the Mobile Wheelchair Platform (K073565) The 'Mobile wheelchair Platform' received good reviews but users expressed a need for a smaller lighter platform that would require a expressed a nood for a timuse. The increase in body mass of the general population required that the new platform should be able to carry higher loads. The complete redesign more than halved the storage area and up-graded the load from a SWL of 594lb to Storage area and up Erdece to 825lbs. The angle of tilt has been altered to 60deg to provide a recovery position. The clinician operating position is optimal. After tilting to 45 The Childclain operating postciation is only 800mm, quite low enough degrees the pation i near not include opinion indicates that this head for normal seated working. Onlyarable with that desired for optimal {2}------------------------------------------------ work, however a large number of clinicians prefer a smaller angle of tilt. A clinical stool with a pump-up rise and fall motion can be used to optimise the seating position if desired By utilising extensive clinical feedback Design Specific has been able to develop a backrest assembly that has vertical adjustment to accommodate a wide range of patient statures in comfort. The previous Mobile platform had a fixed height backrest. The Wheelchair platform is supported on two side frames with a high pivot point. The hydraulic cylinders are below the pivot and retract to tilt the platform. This gives a very compact form and with a hinged platform base the whole unit is no more than 24" wide. It can be easily moved through doors for sharing with other opertories. The whole construction is aerospace high strength aluminium alloys or stainless steel giving a high strength weight ratio. The unit is powered at 24v. The main source of power is from a pair of 12v lead acid batteries that can be easily replaced and last for at least 40 full cycles before needing to be recharged. A dc supply is provided to operate the machine from the mains supply if needed. The control is via a PCB with a PIC logic controller. All switching takes place at 5v and makes the controls light and reliable. The logic capability allows continuous monitoring of safety switching and the integration of good safety procedures. A radio handset is normally used to control the platform eliminating any trailing wires Safety is a major concern and entrapment is eliminated by using sensitive, fail-safe, strip switches at all sensitive points on the mechanism. . The radio handset and fixed switches on the machine are supplied to operate the device, duplicating the control function. All control and drive elements are housed safely under a cover. The machine has clean lines and is easily cleaned with wipe over surfaces. The wheelchair Platform is to treat patients that cannot reasonably Intended use be removed from their chairs and transported to another device. The concerns would include health and safety of the clinical staff and the patients, medical conditions of the patient and the special nature of some wheelchairs. Clinical environments, particularly dental opertories, would be high in the order of need others would be Maxio facial, ear nose and throat, eye treatments. Design {3}------------------------------------------------ ### Technical Characteristics . · ・・・・・・・・ :" . : . ・ - · --- ・・・ ـ ﻓ ﻧ : ﻨ : : : :: . . · | Characteristic | Design Specific<br>Wheelchair Platform | Compact Wheelchair<br>Platform | |-----------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | Basic Platform Shape | Steel Fabrication | Aluminium and Stainless<br>steel | | Drive mechanism | Electrical Linear Drive | Hydraulic operation | | Power source | Battery 24v and Power<br>supply delivering 24v | Battery 24v and Power<br>supply delivering 24v | | Backrest support | Pivots in and out<br>adjustable by worm and<br>wheel. Fixed height<br>backrest pad | Pivots in and out<br>adjustable by worm and<br>wheel. Adjustable height<br>backrest pad | | Headrest | Adjustable using a<br>slotted arm with an<br>adjustable headrest<br>cushion for neck and<br>head support. | Adjustable using a<br>slotted arm with an<br>adjustable headrest<br>cushion for neck and<br>head support | | Wheelchair type | All types including<br>battery driven<br>wheelchairs and specially<br>moulded chairs | All types including<br>battery driven<br>wheelchairs and specially<br>moulded chairs | | Command input | Fixed switches on the<br>mechanism cover and<br>remote radio transmitter<br>handset. | Fixed switches on the<br>mechanism cover and<br>remote radio transmitter<br>handset. | | Foot crush protection | Pressure sensitive mat<br>and guarding | Pressure sensitive strip<br>switches | | Max. angle of tilt | 45deg | 60deg | | Rated capacity | 594lb (BSEN1570:1999) | 660lb (BSEN1570:1999) | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Design Specific Ltd. % Mr. Richard Fletcher Unit 10 Caburn Enterprise Park The Broyle Ringmer East Sussex United Kingdom BN8 5NP DEC 2 3 200 Re: K101723 Trade/Device Name: Compact Reclining Wheelchair Platform Regulation Number: 21 CFR 890.3110 Regulation Name: Electric positioning chair Regulatory Class: Class II Product Code: INO Dated: October 18, 2010 Received: November 3, 2010 Dear Mr. Fletcher: 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 iddictions for use stated in the enclosure) to legally marketed predicate devices marketed in intestate 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, Dr 10 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 libility warranties. We remind you; however, that device labeling must be truthful and not miseading. 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 {5}------------------------------------------------ Page 2 - Mr. Richard Fletcher 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/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 yours. A.S. R. Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications for use 510(k) Number: K101723 DEC 2 3 2010 Compact Reclining Wheelchair Platform Device Name: Indications for use: The clinical treatment of persons in wheelchairs presents a significant issue for The cannon freathigh of personedures related to a patient's head often require them confident and patients anke. I receining the wheelchair giving full support to both to be rechnict. It planetin for for working environment for both patient and clinician. The hazards associated with transfers to other couches or chairs are eliminated. Typical treatments would include: - . Dental - Maxiliofacial work . - Ear, Nose and Throat procedures . - Eye treatments and surgery . - Podiatry . Over-The-Counter Use X, AND/OR Prescription Use × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS) LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Division of Surgical, Orthopedic, a storative Devices 5.0(k) Number K101723