(268 days)
No
The device description details a manual wheelchair with mechanical adjustments and features. There is no mention of AI, ML, or any computational processing that would suggest the use of such technologies. The performance studies are based on mechanical and material standards.
No
This device provides mobility and comfort for users but does not state any therapeutic claims or functions designed to treat or alleviate a medical condition.
No
The device is a manual wheelchair designed to provide mobility; it does not mention any diagnostic capabilities.
No
The device description clearly outlines a physical, manual wheelchair with various adjustable hardware components (headrest, armrests, seat, wheels, 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Merits Model R106/R136 Rehab Wheelchair is a manual wheelchair designed to provide mobility to individuals with limited sitting ability. It is a physical device used for support and transportation, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any components, processes, or intended uses related to collecting, analyzing, or interpreting biological specimens.
Therefore, based on the provided information, the Merits Model R106/R136 Rehab Wheelchair is a mobility aid, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Merits Model R106/R136 Rehab Wheelchair is to provide mobility to persons limited to a sitting position.
Product codes
IOR
Device Description
The Merits Model R106/R136 Rehab Wheelchair are manual wheelchairs. They have adjustable headrest, adjustable armrests, cozy ergonomics seat and multiple axle position. The seat and back are supported by two cylinders, so the fully back reclines can be adjusted from 9° to 57° and seat tilting angles from 4° to 34°. The casters are 7"*1" PU wheels with height adjustable forks and the rear wheels are 24"*1-3/8" polyurethane spoke wheels (R106) or 12-1/2"*2-1/4" polyurethane spoke wheels (R136). The wheelchair also has a shear reduction system: by carefully aligning the pivot points of the user and the Recline Backrest of the wheelchair, to minimize the sliding down of the user and also minimize the shear force and pressure against the back. The armrest height can be adjusted from 8" to 12". Its seat width is also adjustable: 16" /17" /18" /19" and 20" and seat depth: 18" /19" and 20".
The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices.
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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)
Non-clinical tests performed for substantial equivalence include:
- ISO 7176-1:2014: Determination of Static Stability
- ISO 7176-3:2012: Determination of effectiveness of brakes
- ISO 7176-5:2008: Determination of overall dimensions, mass and maneuvering space
- ISO 7176-7:1998: Method of Measurement of Seating and Wheel Dimensions
- ISO 7176-8:2014: Requirements and test methods for static, impact and fatigue strengths
- ISO 7176-11:2012: Test dummies
- ISO 7176-13:1989: Determination of coefficient of friction of test surfaces
- ISO 7176-15:1996: Requirements for Information Disclosure, Documentation and Labeling
- ISO 7176-16:2012: Resistance to ignition of postural support devices
- ISO 14971:2007: Medical devices -- Application of risk management to medical devices
- ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Results: The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ORION II (Heavy Duty 350lbs and 500lbs) mechanical wheelchair (K101277)
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The word "Administration" is on the second line.
November 16, 2017
Merits Healthcare Industries (suzhou) Co., Ltd. Guangyong Li Manager No.29, Fuzhou Road Taicang City, 215411 CN
Re: K170517
Trade/Device Name: Merits Model R106/R136 Rehab Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 29, 2017 Received: October 19, 2017
Dear Guangyong Li:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michaelリ. Hoffmann -S
Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170517
Device Name
Merits Model R106/R136 Rehab Wheelchair
Indications for Use (Describe)
The Merits Model R106/R136 Rehab Wheelchair is to provide mobility to persons limited to a sitting position.
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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3
510(k) SUMMARY
Merits Healthcare Industries. (suzhou) Co., LTD. 510(k) Premarket Notification K170517
Submitter:
Merits Healthcare Industries. (suzhou) Co., LTD. No.29, Fuzhou Road, Taicang City. Jiangsu province, China.
Contact Person:
Guangyong Li Merits Healthcare Industries. (suzhou) Co., LTD. No.29, Fuzhou Road, Taicang City. Jiangsu province, China. Phone: +86-512-53510000 ext.211 Fax: +86-512-82775985
Date Prepared:
November 15, 2017
Proprietary Name:
Merits Model R106/R136 Rehab Wheelchair
Common name:
Manual Wheelchair
Classification name:
Wheelchair, Mechanical
Product Code:
IOR
Indications for Use
The Merits Model R106/R136 Rehab Wheelchair is to provide mobility to persons limited to a sitting position.
4
The Predicate Device:
This submission indicates the Substantial Equivalence of the Merits Model R106/R136 Rehab Wheelchair, with the predicate ORION II (Heavy Duty 350lbs and 500lbs) mechanical wheelchair (K101277). R106/R136 has the same intended uses and similar indications, technological characteristics and principles of operation with predicate device.
Device Description
The Merits Model R106/R136 Rehab Wheelchair are manual wheelchairs. They have adjustable headrest, adjustable armrests, cozy ergonomics seat and multiple axle position. The seat and back are supported by two cylinders, so the fully back reclines can be adjusted from 9° to 57° and seat tilting angles from 4°
to 34° . The casters are 7"*1" PU wheels with height adjustable forks and the rear wheels are 24"*1-3/8" polyurethane spoke wheels (R106) or 12-1/2"*2-1/4" polyurethane spoke wheels (R136). The wheelchair also has a shear reduction system: by carefully aligning the pivot points of the user and the Recline Backrest of the wheelchair, to minimize the sliding down of the user and also minimize the shear force and pressure against the back. The armrest height can be adjusted from 8" to 12". Its seat width is also adjustable: 16" /17" /18" /19" and 20" and seat depth: 18" /19" and 20".
The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices.
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
5
Discussions of Non-clinical Tests Performed for Determinations of Substantial equivalence are as follows:
| ISO 7176-1:2014 | Determination of Static Stability |
|---|---|
| ISO 7176-3:2012 | Determination of effectiveness of brakes |
| ISO 7176-5:2008 | Determination of overall dimensions, mass and maneuvering |
| space | |
| ISO 7176-7:1998 | Method of Measurement of Seating and Wheel Dimensions |
| ISO 7176-8:2014 | Requirements and test methods for static, impact and fatigue |
| strengths | |
| ISO 7176-11:2012 | Test dummies |
| ISO 7176-13:1989 | Determination of coefficient of friction of test surfaces |
| ISO 7176-15:1996 | Requirements for Information Disclosure, Documentation and |
| Labeling | |
| ISO 7176-16:2012 | Resistance to ignition of postural support devices |
| ISO 14971:2007 | Medical devices -- Application of risk management to medical |
| devices | |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in |
| vitro cytotoxicity | |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for |
| irritation and skin sensitization |
The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
6
Comparison of the Technological Characteristics:
The Merits Model R106/R136 Rehab Wheelchair, is substantially equivalent to the ORION II (Heavy Duty 350lbs and 500lbs) mechanical wheelchair (K101277). Both products are mechanical designed for use as personal manual mobility aids. Performance characteristics and drive mechanisms are similar and all have the same intended function and use which is to provide mobility to persons limited to a sitting position. Additional, they are all constructed from the same basic materials, have the same basic operational principles or operated by others. The comparison table is as follow:
| Characteristics | | The Merits Model
R106 Rehab
Wheelchair | The Merits Model
R136 Rehab
Wheelchair | ORION II (Heavy Duty
350lbs and 500lbs)
mechanical
wheelchair (K101277) |
|-----------------------------------|--------|---------------------------------------------------------------------|---------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Indications for Use | | To provide mobility to
persons limited to a
sitting position. | To provide mobility to
persons limited to a
sitting position. | To provide mobility to
persons limited to a
sitting position. |
| Dimension | Length | 47.5" (±1") | 44.5(±1") | 47" |
| | Width | 28-32" (±1") | 26"-30" (±1") | 24.5-33.5" |
| | Height | 42" (±1") | 42" (±1") | 42" |
| Weight | Total | 89 lbs | 62 lbs | 65 lbs |
| Weight Capacity | | 300 lbs | 300 lbs | 350 lbs |
| Seat width | | 16-20" | 16-20" | 15-24" |
| Seat height | | 19-21" | 21" | 16-20" |
| Seat depth | | 18-20" | 18-20" | 15-24" |
| Tires | | Front: 7"/ Rear: 24" | Front: 7"/ Rear: 12-1/2" | Front: 4",5",6",7",8"/
Rear: 12",20",22",24" |
| Headrest | | Adjustable | Adjustable | Adjustable |
| Armrest | | Height Adjustable
(8"~12") | Height Adjustable
(8"~12") | Height Adjustable
(9-1/2"~14") |
| Back Recline | | 9°~57° | 9°~57° | 6°~36°(Optional) |
| Seat Tilt | | 4°~34° | 4°~34° | 3°~48° |
| Elevating Legrest | | Standard | Standard | Optional |
| Seat/Backrest Pad | | Cozy Ergonomics PU
Foam | Cozy Ergonomics PU
Foam | Cozy Ergonomics PU
Foam |
| Rear Axle Position | | Multiple | Fixed | Multiple |
| Shear Reduction | | Aligned Backrest
Recline & User Pivot
Points | Aligned Backrest
Recline & User Pivot
Points | None |
| Hand Brake
(Brake Force/Dist.) | | 13.5N/0.5M | 13.5N/0.5M | 13.5N/0.5M |
| Frame Construction | | Fixed Frame
(Not foldable) | Fixed Frame
(Not foldable) | Fixed Frame
(Not foldable) |
| Frame Material | | Steel | Steel | Steel |
| Turning Radius | | 30"35.8"91cm) | 32"
(76.5cm38.1"96.8cm) | 28"
(81.5cm37"94cm) |
(71cm
| Safety Feature | | Manual Wheel Lock | Manual Wheel Lock | Manual Wheel Lock |
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The comparison of the technical details between R106/R136 and its predicate device are summarized in the following:
- a. Dimension: The dimensions of our device and the predicate are similar. And our device has passed ISO 7176-1:2014 (Determination of Static Stability) and ISO 7176-2:2001(Determination of Dynamic Stability of electric wheelchairs). So there is no deleterious affection of safety and effectiveness about the difference on Dimension with predicated device.
- b. Weight: Although the total weight of R106/R136 is heavier than ORION II (Heavy Duty 350lbs and 500lbs) mechanical wheelchair (K101277). The device has passed ISO 7176-8 (Requirements and test methods for static, impact and fatigue strengths) test (Please see Appendix IV: Test reports). So there is no deleterious affection of safety and effectiveness about the difference on Weight with predicate device.
- c. Cozy Ergonomics Seating System: Both of our devices and the predicate are equipped with similar Cozy Ergonomics PU foam Seat/Backrest Pad, adjustable Headrest and Armrest which can offer the most comfortable seating experiences to users. Our R106/R136 is supplied with a standard Elevating Legrest, while the predicated device is provided it as an option. The Elevating Legrest can provide better strain-relief for legs.
- d. Multiple Rear Axle Position: Both our R106 and the predicate device are provided with Multiple Rear Axle Positions to allow users to change its seat height to a best fitting position. But for the attendant control wheelchair, the seat height adjustment is not as important as the stability, so a Fixed Rear Axle Position is used on our R136 device to achieve the most stable position.
- e. Shear Reduction: On the predicated device, the Reclined Backrest and user pivot points are not aligned resulting in a non-synchronized movement. As a result, when it reclines, the headrest and back support move up, forcing the user to slide down the chair to compensate. This leads to shear and friction forces. Our R106/R136 devices are carefully designed to align the pivot points of the user and the Recline Backrest of the wheelchair. This minimizes the sliding down of the user while reclining the backrest. And this also minimizes the shear force and pressure against the back.
- f. Frame Construction and material: Both of our devices and the predicated device are the same steel, fixed frames.
- g. Safety Feature: Both of our devices and the predicated device are equipped with Manual Wheel Locks to prevent unexpected movement while parking.
The minor differences between R106/R136 and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the R106/R136 is safe.
8
Conclusions
According to comparison table, the differences on weight capacity, adjustable back angle, adjustable armrest height and dimensions do not deleteriously affect the safety and effectiveness of the device.
The non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do no raise any new questions of safety or effectiveness.
So based on the design, performance specifications and testing and intended use, The Merits Model R106/R136 Rehab Wheelchair, is substantially equivalent to the ORION II (Heavy Duty 350lbs and 500lbs) mechanical wheelchair (K101277).