(104 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on mechanical and structural aspects of a manual wheelchair, with no mention of AI or ML.
No
A wheelchair provides mobility, but it does not directly treat or cure a disease, injury, or condition.
No
The device is a manual wheelchair, whose intended use is to provide mobility. It does not perform any diagnostic functions.
No
The device description clearly describes a physical, mechanical wheelchair with components like a base frame, seat frame, struts, and tilt arcs. The performance studies also focus on physical characteristics and testing of a hardware device (stability, brakes, dimensions, strength, etc.). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is a "Manual Wheelchair" intended to "provide mobility to persons." This is a physical mobility aid, not a device that performs tests on biological samples.
- Intended Use: The intended use is to "provide mobility," which aligns with a physical assistance device, not a diagnostic test.
- Performance Studies: The performance studies listed are related to the physical characteristics and safety of a wheelchair (stability, brakes, dimensions, strength, etc.), not the accuracy or reliability of a diagnostic test.
The information provided definitively indicates that this device is a medical device for mobility, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The P.R.O. CG® Manual Wheelchair is intended to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 250lbs.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The P.R.O. CG® Manual Wheelchair is a rigid, non-folding, manually operated, center of gravity shifting (CG) tilt-in-space wheelchair. The design incorporates a fixed width base frame that is connected to a width and depth adjustable seat frame with struts connected to tilt arcs. This design allows the seat frame to change its position using a CG shifting tilt motion. The shift moves to reposition the seat frame angle from 0° to 50° in a smooth, downward, forward, and backward motion with little change in the overall center of gravity of the frame and the occupant. The device is not marketed with upholstery in the standard or optional configurations. The subject device intended use is to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 2501bs.
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
ages 12 and up (adolescents and adults)
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 laboratory testing was performed on the subject P.R.O. CG® Manual Wheelchair to determine substantial equivalence. The following testing was performed:
- ISO International Standard 7176-1: Determination of Static Stability .
- ISO International Standard 7176-3 : Determination of Effectiveness of Brakes .
- ISO International Standard 7176-5: Determination of Dimensions, Mass and ● Maneuvering Space
- ISO International Standard 7176-7: Measurement of Seating and Wheel Dimensions .
- . ISO International Standard 7176-8: Requirements and Test Methods for Static, Impact and Fatigue Strengths
- ISO International Standard 7176-11: Test dummies .
- ISO International Standard 7176-13: Determination of Coefficient of Friction of Test . Surfaces
- ISO International Standard 7176-15: Requirements for Information Disclosure, . Documentation and Labeling
- ISO International Standard 7176-19: Wheeled Mobility Device for Use in Motor . Vehicles Annex A. C and D
- ANSI/RESNA WC-4: 2012, Section 19: Wheelchairs Used as Seats in Motor Vehicles . Annex A, B, C and E
- CAL117:2013, Section 1: Flammability Testing .
Testing demonstrated that the subject P.R.O. CG® Manual Wheelchair is substantially equivalent to the marketed predicate device.
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.
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.
No reference devices were used in this submission.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 image of three human profiles facing right, stacked on top of each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2015
Freedom Designs, Inc. Nancy F. Schmidt Manager, Customer Relations 2241 Madera Road Simi Valley, CA 93065
Re: K151893
Trade/Device Name: P.R.O. CG Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 24, 2015 Received: September 25, 2015
Dear Ms. Schmidt:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
Michael J. Hoffmann -A
for Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151893
Device Name P.R.O. CG Manual Wheelchair
Indications for Use (Describe)
The P.R.O. CG® Manual Wheelchair is intended to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 2501bs.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary K151893 | |
|---|---|
| SUBMITTER: | Freedom Designs, Inc. |
| 2241 Madera Road | |
| Simi Valley, CA 93065 | |
| Phone: (805) 915-1133 | |
| CONTACT PERSON: | Nancy F. Schmidt |
| Manager - Customer Relations/Quality Management | |
| Representative | |
| Date Prepared: | October 22, 2015 |
| DEVICE | |
| Name of Device: | P.R.O. CG® Manual Wheelchair |
| Common or Usual Name: | Wheelchair, mechanical |
| Classification Name: | Mechanical wheelchair 21 CFR §890.3850 |
| Regulatory Class: | I |
| Product Code: | IOR: Wheelchair, mechanical |
| PREDICATE DEVICE: | Manual Rigid Mobility Wheelchair (K080270) |
| No reference devices were used in this submission. |
DEVICE DESCRIPTION
This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to Market the P.R.O. CG® Manual Wheelchair. The P.R.O. CG® Manual Wheelchair is a rigid, non-folding, manually operated, center of gravity shifting (CG) tilt-in-space wheelchair. The design incorporates a fixed width base frame that is connected to a width and depth adjustable seat frame with struts connected to tilt arcs. This design allows the seat frame to change its position using a CG shifting tilt motion. The shift moves to reposition the seat frame angle from 0° to 50° in a smooth, downward, forward, and backward motion with little change in the overall center of gravity of the frame and the occupant. The device is not marketed with upholstery in the standard or optional configurations. The subject device intended use is to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 2501bs.
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INDICATIONS FOR USE
The P.R.O. CG® Manual Wheelchair is intended to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 250lbs.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The device comparison showed that the subject device is substantially equivalent in intended use, design and operational principles to the previously cleared Manual Rigid Mobility Wheelchair (K080270). The subject device is substantially equivalent to the predicate device in regards to intended use, design, materials, and operational principles to provide mobility to persons limited to a sitting position.
PERFORMANCE DATA
Non-Clinical Test
Non-clinical laboratory testing was performed on the subject P.R.O. CG® Manual Wheelchair to determine substantial equivalence. The following testing was performed:
- ISO International Standard 7176-1: Determination of Static Stability .
- ISO International Standard 7176-3 : Determination of Effectiveness of Brakes .
- ISO International Standard 7176-5: Determination of Dimensions, Mass and ● Maneuvering Space
- ISO International Standard 7176-7: Measurement of Seating and Wheel Dimensions .
- . ISO International Standard 7176-8: Requirements and Test Methods for Static, Impact and Fatigue Strengths
- ISO International Standard 7176-11: Test dummies .
- ISO International Standard 7176-13: Determination of Coefficient of Friction of Test . Surfaces
- ISO International Standard 7176-15: Requirements for Information Disclosure, . Documentation and Labeling
- ISO International Standard 7176-19: Wheeled Mobility Device for Use in Motor . Vehicles Annex A. C and D
- ANSI/RESNA WC-4: 2012, Section 19: Wheelchairs Used as Seats in Motor Vehicles . Annex A, B, C and E
- CAL117:2013, Section 1: Flammability Testing .
5
Testing demonstrated that the subject P.R.O. CG® Manual Wheelchair is substantially equivalent to the marketed predicate device.
Animal Study
Animal testing was not required for this submission.
Clinical Testing
Clinical testing was not required for this submission.
CONCLUSIONS
The subject device has the same intended use and similar technological characteristics as the predicate device. The non-clinical laboratory data support the safety of the subject P.R.O. CG® Manual Wheelchair and demonstrate that the subject device should perform as intended in the specified use conditions. Therefore, the subject P.R.O. CG® Manual Wheelchair is substantially equivalent to the predicate device identified throughout this submission.