(112 days)
Not Found
No
The device description details a purely mechanical wheelchair with a rocking and tilt feature controlled by springs, cables, and levers. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended to redistribute pressures exerted on the buttocks and lower back, provide comfort adjustment, and assist in positioning, which are therapeutic benefits.
No
The device is a wheelchair designed to provide mobility and comfort, and to redistribute pressure. It does not perform any diagnostic functions like detecting, monitoring, or predicting a medical condition.
No
The device description clearly outlines a mechanical wheelchair with physical components like an aluminum frame, wheels, casters, springs, and cables. There is no mention of software being a primary or even significant component of the device's function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The URok Rocking Wheelchair is a mechanical device designed to provide mobility, pressure redistribution, and comfort through rocking and tilting. It interacts with the user externally and does not involve the analysis of biological samples.
- Intended Use: The intended use clearly describes a mobility aid and pressure management device, not a diagnostic test.
- Device Description: The description focuses on the mechanical components and features of a wheelchair.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or any other activity related to in vitro diagnostics.
Therefore, the URok Rocking Wheelchair falls under the category of a medical device, but specifically a mobility and seating device, not an IVD.
N/A
Intended Use / Indications for Use
The URok Rocking Wheelchair is intended to provide mobility to persons limited to a sitting position while the rocking mechanism is locked in an upright position.
The wheelchair is intended to redistribute pressures exerted on the buttocks and lower back when rocking or tilted at an angle.
The wheelchair is intended to provide comfort adjustment while rocking or tilted at an angle.
AMG Medical inc. recommends that an accredited rehabilitation or occupational therapist and supplier evaluate all customers of its products.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The AMG Medical Inc. URok Rocking Wheelchair is a manually operated, attendant or user propelled, mechanical rocking wheelchair. The device is a lightweight wheelchair, suitable for both indoor and outdoor use.
The device consists of an aluminum frame, one size of rear wheel, and smaller front pivoting casters for steering and turning. The frame is constructed from aluminum tubing that is TIG-welded. This device is a rigid, non-folding type of wheelchair that incorporates a padded, sling style seat. The upholstery meets the requirements of ISO 7176-16, flammability standards.
The AMG URok Rocking Wheelchair includes a rocking feature which permits dynamic pressure management of the seating pressure upon the buttocks. The rocking feature is realized by the placement of two vertically positioned fibrogless Ieaf springs, which are connected to the seat and frame, under the seat's centre of gravity. The balance of the seat upon the springs is precise enough so that the rocking motion may be initiated by the user simply by gently moving the head backward and forward. Safety features such as anti tippers and rock arrestors limit the arc of the rocking motion. The rocking feature can be "locked out" by an attendant so that the device can be used as a wheelchair with no rocking motion.
The AMG URok wheelchair also has a "tilts in space" feature. The rocking mcchanism can be locked in multiple positions to provide "tilt in space" that permits receing meemainst backwards thereby allowing gravity to hold them in position. This is used to help in positioning, comfort, or head control. The tilt in space is initiated by the attendant pushing down on the push handles to tilt the scat and back and locking out the rocking action when the desired angle of tilt is reached.
The rocking feature is released or is locked out by two cable controlled pins that insert into holes within two vertically mounted metal plates located under the seat support tubes. The cables are controlled using bicycle brake type levers in onto bed on the rear push tube or handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Buttocks and lower back
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)
The AMG URok Rocking Wheelchair meets the performance requirements specified in the ANSI/RESNA WC series of wheelchair requirements.
Pressure redistribution obtained while rocking was observed and recorded using adult human volunteers seated on a pressure recording mat placed upon the seat cushion.
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.
K902438, Invacare Solara wheelchair
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
JAN 6 2006
510(k) SUMMARY
AMG Medical Inc.'s URok Rocking Wheelchair
Submitter,s Name, address, Telephone Number, Contact Person and Date Prepared AMG Medical Inc. 8505 Dalton Montreal, Canada H4T IV5 514-737-5251 Phone: Fax: 514-737-6572
Kenneth Levesque Contact Person: Director, RA/QA
Date Prepared:
September 07, 2005
Name of Device and Name/Address of Sponsor
URok Rocking Wheelchair AMG Medical Inc. 8505 Dalton Montreal, Canada H4T 1V5 514-737-5251 Phonc: 514-737-6572 Fax:
Common or Usual Name: Manual Wheelchair
Classification Name:
Wheelchair, Mechanical 89IOR
Predicate Devices:
The URok Rocking Wheelchair is substantially equivalent to the RxRocker (K902438) wheelchair for the rocking feature.
The URok Rocking Wheelchair is substantially equivalent to the Invacare Solara wheelchair for the pressure redistribution feature.
Background
In 2001 AMG Medical Inc. purchased all rights to the RxRocker Corp. with the exception of the following: AMG granted RxRocker Corp. the right to continue to sell the RxRocker only to the US Government (including the Veteran's Administration and US military hospitals under the patents and existing technology and know how found the RxRocker wheelchair.
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In consideration of the above sales agreement and continuing sales of the original 510k device, AMG is not submitting this 510k for a change to an existing device but rather submitting for a new 510k premarket approval referencing the RxRocker as a predicate device.
Intended Use:
The URok Rocking Wheelchair is intended to provide mobility to persons limited to a sitting position while the rocking mechanism is locked in an upright position.
The wheelchair is intended to redistribute pressures exerted on the buttocks and lower back when rocking or tilted at an angle.
The wheelchair is intended to provide comfort adjustment while rocking or tilted at an angle.
Technological Characteristics
The AMG Medical Inc. URok Rocking Wheelchair is a manually operated, attendant or user propelled, mechanical rocking wheelchair. The device is a lightweight wheelchair, suitable for both indoor and outdoor use.
The device consists of an aluminum frame, one size of rear wheel, and smaller front pivoting casters for steering and turning. The frame is constructed from aluminum tubing that is TIG-welded. This device is a rigid, non-folding type of wheelchair that incorporates a padded, sling style seat. The upholstery meets the requirements of ISO 7176-16, flammability standards.
The AMG URok Rocking Wheelchair includes a rocking feature which permits dynamic pressure management of the seating pressure upon the buttocks. The rocking feature is realized by the placement of two vertically positioned fibrogless Ieaf springs, which are connected to the seat and frame, under the seat's centre of gravity. The balance of the seat upon the springs is precise enough so that the rocking motion may be initiated by the user simply by gently moving the head backward and forward. Safety features such as anti tippers and rock arrestors limit the arc of the rocking motion. The rocking feature can be "locked out" by an attendant so that the device can be used as a wheelchair with no rocking motion.
The AMG URok wheelchair also has a "tilts in space" feature. The rocking mcchanism can be locked in multiple positions to provide "tilt in space" that permits receing meemainst backwards thereby allowing gravity to hold them in position. This is used to help in positioning, comfort, or head control. The tilt in space is initiated by the attendant pushing down on the push handles to tilt the scat and back and locking out the rocking action when the desired angle of tilt is reached.
The rocking feature is released or is locked out by two cable controlled pins that insert into holes within two vertically mounted metal plates located under the seat support tubes. The cables are controlled using bicycle brake type levers in onto bed on the rear push tube or handle.
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2
Substantial equivalence:
The AMG URok Rocking Wheelchair is substantially equivalent to numerous manual, mechanical wheelchairs currently in the marketplace, for which FDA has granted marketing clearance through the 510(k) premarket notification process. More specifically the AMG rocking wheelchair is substantially equivalent to the RxRocker (K902438) wheelchair for it's rocking feature and to the Invacare Solara wheelchair for it's pressure redistribution feature.
Each of the products is manually operated, attendant or user propelled with the same intended functions and uses which are to provide mobility to persons that may be limited to a seated position and to provide pressure relief. Additionally, in one wheelchair pressure relief is achieved either by rocking or by "tilt in space" (URok Rocking Wheelchair) and in the other wheelchair pressure redistribution is achieved solely by "tilt in space" (Invacare Solara).
Performance data:
The AMG URok Rocking Wheelchair meets the performance requirements specified in the ANSI/RESNA WC series of wheelchair requirements.
Pressure redistribution obtained while rocking was observed and recorded using adult human volunteers seated on a pressure recording mat placed upon the seat cushion.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 6 2006
Mr. Kenneth Levesque A.M.G. Medical, Inc. 8505 Dalton Montreal, Quebec H4T 1V5 CANADA
Re: K052548
Trade/Device Name: URok rocking wheelchair, Model 700-4xx Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: II Product Code: IOR Dated: December 21, 2005 Received: December 22, 2005
Dear Mr. Levesque:
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.
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.
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Page 2 - Mr. Levesque
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 premained modicate 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,
Mark N. Melkerson
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known):
Device Name: URok Rocking Wheelchair
Indications for Use:
The URok Rocking Wheelchair, by AMG Medical Inc., is intended to provide mobility to persons limited to a sitting position while the rocking mechanism is locked in an upright position.
The wheelchair is intended to redistribute pressures exerted on the buttocks and lower back when rocking or tilted at an angle.
The wheelchair is intended to provide comfort adjustment while rocking or tilted at an angle.
AMG Medical inc. recommends that an accredited rehabilitation or occupational therapist and supplier evaluate all customers of its products.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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
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