(15 days)
Not Found
No
The device description and performance studies focus on mechanical aspects and standard wheelchair testing, with no mention of AI or ML.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is a wheelchair, which provides mobility assistance but does not treat or prevent a medical condition.
No
The device, a wheelchair, is intended to provide mobility to individuals and does not perform any diagnostic functions.
No
The device description clearly states it is a "mechanical wheelchair" and lists various physical components and mechanical tests, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to adult persons with limited mobility. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a mechanical wheelchair. It does not involve any reagents, instruments, or procedures for examining specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, monitoring, or treatment decisions based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This wheelchair does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of the 7000 Series Lightweight Wheelchair is to provide mobility to adult persons with limited mobility or adult persons limited to a seated position. The target population for the 7000 Series Lightweight Wheelchair is the United States adult population.
Product codes
IOR
Device Description
The 7000 Series Lightweight Wheelchair is mechanical wheelchair that is lightweight in design (weighs 31.5 lbs) and provides mobility to persons with limited mobility or persons limited to a sitting position. The 7000 Series Lightweight Wheelchair comes in 16", 18" and 20" seat widths and has component adjustments for optimum fitting. The 7000 Series Lightweight Wheelchair has dual crossbar support, flip back removable arms, flame retardant nylon upholstery, removable footrests with heel loops, dual axle positioning and wheel locks.
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
adult persons
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)
Non-Clinical Testing:
ISO 7176-16: Resistance to Ignition of Upholstered Parts - California Technical Bulletin 117 - Flammability Testing: Passed
ISO 1421: Upholstery Strength Test
Nova Orthopedic and Rehabilitation Appliance Inc. - The On Road Test for Durability: Test Date - March 16 - 25, 2005
- Running Speed: 60 rpm
- Weight Load: 163 kgf
- Motion Test and Brakes Test passed
- Static, Impact and Strength Test passed
ISO 7176-11: Test Dummies
ISO 7176-13: Determination of Coefficient of Friction of Test Surfaces
ISO 7176: Determine of Effectiveness of Brakes
ISO 7176-15: Requirements for information disclosure, documentation and labeling.
ISO 7176-1: Determination of Static Stability
ISO WC: Determination of Overall Dimensions, Mass and Turning Space
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).
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p. 1/2
MAY 2 3 2006
Image /page/0/Picture/3 description: The image shows the logo for NOVA ORTHO-MED, INC. The word "NOVA" is in large, stylized letters at the top of the logo. Below that, the words "ORTHO-MED, INC." are printed in a smaller, sans-serif font. Underneath that, the phrase "Commitment to Caring" is printed in an italicized font.
510(k) Summary Nova Ortho-Med, Inc. 7000 Series Lightweight Wheelchairs
Submitter's Name and Address
Nova Ortho-Med, Inc. P.O. Box 3039 Gardena, CA 90247 Phone: (310) 352-3600 Fax: (310) 352-3610
Physical Address Location: 1470 Beachey Place Carson, CA 90746
Contact Person: Sue Chen President, CEO Nova Ortho-Med. Inc.
Date Prepared: October 10, 2005
Name of Device and Proprietary Name: 7000 Series Lightweight Wheelchairs
Common or Usual Name: Manual Wheelchair
Classification Name: Wheelchair, Mechanical
Product Code: IOR
Regulation Number: 890.3850
Regulatory Class: Class 1
Comparison to Predicate Devices:
The 7000 Series Lightweight Wheelchair is substantially equivalent to the Invacare 9000 Series Wheelchair (K881951)
Device Description:
The 7000 Series Lightweight Wheelchair is mechanical wheelchair that is lightweight in design (weighs 31.5 lbs) and provides mobility to persons with limited mobility or persons limited to a sitting position. The 7000 Series Lightweight Wheelchair comes in 16", 18" and 20" seat widths and has component adjustments for optimum fitting. The 7000 Series Lightweight Wheelchair has dual crossbar support, flip back removable arms, flame retardant nylon upholstery, removable footrests with heel loops, dual axle positioning and wheel locks.
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Intended Use:
The intended use of the 7000 Series Lightweight Wheelchair is to provide mobility to adult persons with limited mobility or adult persons limited to a seated position. The target population for the 7000 Series Lightweight Wheelchair is the United States adult population.
Non-Clinical Testing:
ISO 7176-16: Resistance to Ignition of Upholstered Parts - California Technical Bulletin 117 - Flammability Testing: Passed
ISO 1421: Upholstery Strength Test
Nova Orthopedic and Rehabilitation Appliance Inc. - The On Road Test for Durability: Test Date - March 16 - 25, 2005
- Running Speed: 60 rpm - Weight Load: 163 kgf
- Motion Test and Brakes Test passed
- Static, Impact and Strength Test passed -
ISO 7176-11: Test Dummies
ISO 7176-13: Determination of Coefficient of Friction of Test Surfaces
ISO 7176: Determine of Effectiveness of Brakes
ISO 7176-15: Requirements for information disclosure, documentation and labeling.
ISO 7176-1: Determination of Static Stability
ISO WC: Determination of Overall Dimensions, Mass and Turning Space
Discussion of Clinical Testing Performed:
N/A
Conclusions:
The 7000 Series Lightweight Wheelchair has the same intended use and similar technological characteristics as the Invacare 9000 Series Wheelchair (K881951). All non-clinical testing and the predicate comparisons show that there are no safety or effectiveness issues or claims that differ from the predicate device cited. This submission complies with the requirements as stated in 21 CFR Part 807 Subpart E, that a new device is substantially equivalent to a predicate device in 21 CFR 890.3850. The conclusion is that the 7000 Series Lightweight Wheelchair is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2,3 2006
Nova Ortho-Med, Inc. % Mr. Daniel W. Lehtonen Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087
Re: K061273
Trade/Device Name: 7000 Series Lightweight Wheelchairs Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: I Product Code: IOR Dated: May 5, 2006 Received: May 8, 2006
Dear Mr. Lehtonen:
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
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Page 2 - Mr. Daniel W. Lehtonen
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. 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 .
Sincerely vours
Hulen Lemons
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Nova Ortho-Med, Inc. The word "NOVA" is in a stylized font, with the letters overlapping each other. Below the word "NOVA" is the text "ORTHO-MED, INC." in a smaller, sans-serif font. Underneath that is the text "Commitment to Caring" in a slightly smaller, italicized font.
Indications for Use
K061273 510(k) Number (if known)_
Device Name: 7000 Series Lightweight Wheelchair
Indications for Use:
The intended use of the 7000 Series Lightweight Wheelchair is to provide mobility to adult persons with limited mobility or adult persons limited to a seated position. The target population for the 7000 Series Lightweight Wheelchair is the United States adult population.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulbert Remer us
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K061273