(10 days)
Not Found
No
The description details a purely mechanical, manually operated wheelchair with no mention of computational or data-driven features.
Yes
The device is intended to provide mobility to persons that may be limited to a sitting position, and its features (seat tilt, strapping) are designed to control slumping and sliding, reduce reliance on restraints, increase comfort, and prevent skin breakdown. These aspects indicate a therapeutic purpose.
No
Explanation: The device description clearly states that the Broda Model 587 Manual Wheelchair is a "manually operated, user propelled mechanical wheelchair" intended to "provide mobility to persons that may be limited to a sitting position." There is no indication throughout the document that it is used for diagnosis of any medical condition.
No
The device description clearly outlines a physical, mechanical wheelchair constructed of steel tubing, wheels, casters, and strapping. It describes hardware components and their physical properties and testing. There is no mention of software as a component or function of the device.
Based on the provided information, the Broda Model 587 Manual Wheelchair is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide mobility to persons limited to a sitting position. This is a mechanical function related to physical support and movement, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description details a mechanical wheelchair with a frame, wheels, casters, and seating components. There is no mention of reagents, calibrators, controls, or any components used for testing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is clearly a medical device intended for physical support and mobility, falling under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The intended use of the Broda Model 587 Manual Wheelchair is to provide mobility to persons that may be limited to a sitting position.
Product codes
IOR
Device Description
The Model 587 Broda Manual Wheelchair is a manually operated, user propelled mechanical wheelchair. The intended use is to provide mobility to persons that may be limited to a sitting position. The product consists primarily of a rigid steel frame, large rear wheels with hand rims for propelling the chair, and smaller front pivoting casters for steering and turning. This is a non-folding rigid type of wheelchair which can be customized for use by patients that weigh up to 250 lbs.
Seat width ranges from a minimum of 14'' wide to a maximum of 20'' wide in two inch increments, with the 16" and 18" widths offered as standard. Seat depths range from a minimum of 15.5" deep to a maximum of 20" deep in 1.5" increments, with the 17" depth offered as standard. Seat to floor dimensions range from 15'' high to 20'' high in 1" increments, with the 19" height offered as standard. Back height ranges from a minimum of 24" high to a maximum of 32" high in 2" increments, with the 24" height offered as standard.
The rigid frame is constructed of round, steel tubing that is MIG welded. The tubing is 1" outside diameter (O.D.) with a wall thickness of 0.065". A rigid, non-folding frame is not used on the predicate device and does not affect the safety and effectiveness of the chair.
The Broda Model 587 Wheelchair offers up to 22 degrees of seat tilt with infinite positioning. The seat tilt controls slumping and sliding, reduces the reliance on restraints, and increases the general comfort level for the occupant. This specification is not available on the predicate devices and does not affect the safety and effectiveness of the chair.
The seat and back are strapped with vinyl strapping that is riveted to the steel tube. The strap is 0.128" thick and 1.5" wide. The strapping is used to better distribute the weight of the occupant, hence reduce the contact pressures on the occupant, which provides added comfort. The strapping also controls heat and moisture buildup and can prevent skin breakdown. The strapping is further covered with a woven polyester/spandex material called Triptex. The strapping is not used on the predicate device and does not affect the safety and effectiveness of the chair.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Broda Model 587 Manual Wheelchair has been tested using the testing methods specified in the Rehabilitation Society of North America (RESNA) Standard ANSI/RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs (Including Scooters)". Results demonstrate that the product meets its' specification. Additionally, the Triptex upholstery meets CAL 117 Standard for flame retardation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
032 133
JUL 2 1 2003
M 510(k) Summary
[As Required by 21 CFR 807.92]
Broda Enterprises Incorporated's Model 587 Manual Wheelchair
| Submitted by: | Broda Enterprises Incorporated
385 Phillip Street
Waterloo, Ontario, Canada N2L 5R8
Phone: (519) 746-8080
Fax: (519) 746-8616 |
| --------------- | ------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Phillip McTaggart Contact Person: Controller, Regulatory Affairs
May 8, 2003 Date Prepared:
Broda Enterprises Inc. Sponsor: 385 Phillip St Waterloo, Ontario, Canada N2L 5R8 Phone: (519) 746-8080 Fax: (519) 746-8616
Broda Model 587 Manual Wheelchair Proprietary Name:
Common Name: Wheelchair
Wheelchair, Manual Class 1 (21 CFR 890.3850) Classification Name:
Predicate Device: Invacare Corporation Model Tracer Series Manual Wheelchair (K935398: March 1, 1994)
The intended use of the Broda Model 587 Manual Wheelchair is Intended Use: to provide mobility to persons that may be limited to a sitting position.
1
Technological Characteristics and Substantial Equivalence
Device Description: The Model 587 Broda Manual Wheelchair is a manually operated, user propelled mechanical wheelchair. The intended use is to provide mobility to persons that may be limited to a sitting position. The product consists primarily of a rigid steel frame, large rear wheels with hand rims for propelling the chair, and smaller front pivoting casters for steering and turning. This is a non-folding rigid type of wheelchair which can be customized for use by patients that weigh up to 250 lbs.
Seat width ranges from a minimum of 14'' wide to a maximum of 20'' wide in two inch increments, with the 16" and 18" widths offered as standard. Seat depths range from a minimum of 15.5" deep to a maximum of 20" deep in 1.5" increments, with the 17" depth offered as standard. Seat to floor dimensions range from 15'' high to 20'' high in 1" increments, with the 19" height offered as standard. Back height ranges from a minimum of 24" high to a maximum of 32" high in 2" increments, with the 24" height offered as standard.
The rigid frame is constructed of round, steel tubing that is MIG welded. The tubing is 1" outside diameter (O.D.) with a wall thickness of 0.065". A rigid, non-folding frame is not used on the predicate device and does not affect the safety and effectiveness of the chair.
The Broda Model 587 Wheelchair offers up to 22 degrees of seat tilt with infinite positioning. The seat tilt controls slumping and sliding, reduces the reliance on restraints, and increases the general comfort level for the occupant. This specification is not available on the predicate devices and does not affect the safety and effectiveness of the chair.
The seat and back are strapped with vinyl strapping that is riveted to the steel tube. The strap is 0.128" thick and 1.5" wide. The strapping is used to better distribute the weight of the occupant, hence reduce the contact pressures on the occupant, which provides added comfort. The strapping also controls heat and moisture buildup and can prevent skin breakdown. The strapping is further covered with a woven polyester/spandex material called Triptex. The strapping is not used on the predicate device and does not affect the safety and effectiveness of the chair.
Substantial Equivalence: The Broda Model 587 Manual Wheelchair is substantially equivalent to the Invacare Tracer Manual Wheelchair (K935398).
Performance Data
The Broda Model 587 Manual Wheelchair has been tested using the testing methods specified in the Rehabilitation Society of North America (RESNA) Standard ANSI/RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs (Including Scooters)". Results demonstrate that the product meets its' specification. Additionally, the Triptex upholstery meets CAL 117 Standard for flame retardation.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2003
Broda Enterprises, Incorporated c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462
Re: K032133
Trade/Device Name: Broda Model 587 Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: II Product Code: IOR Dated: July 10, 2003 Received: July 11, 2003
Dear Mr. Mosenkis:
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
3
Page 2 - Mr. Robert Mosenkis
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. 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 (301) 594-4659. 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/dsmamain.html
Sincerely yours,
L. Mark A. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use B
Broda Enterprises Incorporated Applicant: 510(k) Number (if known): . TBD Broda Model 587 Manual Wheelchair
Indications For Use:
Device Name:
The intended use of the Broda Model 587 Manual Wheelchair is to provide mobility to persons that may be limited to a sitting position.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number __ K032133
(Optional Format 1-2-96)