(211 days)
Not Found
No
The device description and intended use clearly define it as a manual wheelchair with no mention of AI or ML capabilities. The testing performed is related to mechanical and safety standards for wheelchairs.
No.
The device is described as a manual wheelchair for mobility, and while it offers features for user comfort like tilt and recline for pressure relief, its primary purpose is not therapeutic treatment or diagnosis of a disease or condition.
No
The device description indicates it is a manual wheelchair, designed for mobility and positioning, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, manual wheelchair with a tubular aluminum frame, wheels, casters, and various hardware components and accessories. It is not a software-only device.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The provided text clearly describes a manual wheelchair designed for mobility for individuals with disabilities. It focuses on mechanical features, safety standards for transportation, and positioning options.
- Intended Use: The intended use is to provide mobility, not to perform diagnostic tests on biological samples.
The description of the Convaid Trekker models aligns with the definition of a medical device (specifically, a mobility aid), but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Convaid Trekker models are manual wheelchairs; Their intended use is to provide mobility to persons with disabilities who are partially or permanently non-ambulatory and limited to a sitting position.
In addition the Trekker models TR12T and TR14T comply with the requirements of RESNA WC4:2012-section 19 Wheelchairs used as seats in motor vehicles.
Product codes (comma separated list FDA assigned to the subject device)
IOR, LBE
Device Description
The Trekker TR12, TR12T and TR14, TR14T are attendant propelled manual wheelchairs. They are lightweight compact folding wheelchairs with tubular 6061 aluminum frames with removable seating modules for easy transport and stowage. The seating module is also reversible to allow the caregiver the option to observe the user during use.
Front small casters for steering and maneuverability and larger wheels in the rear. A tilt function for pressure relief and the recline function provide adjustability for the lower extremities.
Foot operated wheel locks provide easy operation.
Positioning options include H-harness, two point seat belt, three point seat belt with crotch pad additional non-positioning accessories include under seat storage basket, adjustable I.V. Pole.
Trekker transit option TR12T and TR14T transit models are identical to the TR12 and TR14 except for the factory installation of four (4) tie-down anchors and required labeling. They meet the requirements for use as seating in motor vehicles when used in conjunction with the vehicle supplied four (4) wheelchair tie-down system that attaches to the four (4) transport anchors on the wheelchair and a three (3) point occupant restraint system in accordance with SAE J2249 or WC4:2012 section 18 that creates the shoulder and lap belt combination that attaches to the wheelchair or to the floor of the vehicle.
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 Testing: Convaid's Trekker manual wheelchairs meet the applicable performance requirements as specified below; ANSI-RESNA WC 1:2009-1, ANSI-RESNA WC 1:2009-5, ANSI-RESNA WC 1:2009-7, ANSI-RESNA WC 1:2009-8, ANSI-RESNA WC 1:2009-11, ANSI-RESNA WC 1:2009-13, ANSI-RESNA WC 1:2009-15, ANSI-RESNA WC 1:2009-16, ANSI-RESNA WC 1:2009-22, ANSI-RESNA WC 1:2009-26, ANSI-RESNA WC 2:2009-3, RESNA WC4:2012 section 19 (Trekker), WCVol.1 section 19:2000 (Champ), ISO 10993-5.
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.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 17, 2014
Convaid Products, Inc. Donald Griggs Ouality Assurance Manager 2830 California Street Torrance, CA 90503
Re: K140416
Trade/Device Name: Trekker TR12 and TR14, Trekker Transit TR12T and TR14T Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR, LBE Dated: August 8, 2014 Received: August 15, 2014
Dear Mr. Griggs:
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. Isting 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
1
device-related adverse events) (21 CFR 803); 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.
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,
Felipe Aquel -S
Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140416
Device Name
Trekker TR12 and TR14; Trekker Transit TR12T and TR14T
Indications for Use (Describe)
The Convaid Trekker models are manual wheelchairs; Their intended use is to provide mobility to persons with disabilities who are partially or permanently non-ambulatory and limited to a sitting position.
In addition the Trekker models TR12T and TR14T comply with the requirements of RESNA WC4:2012-section 19 Wheelchairs used as seats in motor vehicles.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
× Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 description: The image shows the logo for Convaid. The logo consists of a blue square with a white curved shape inside, followed by the word "Convaid" in black sans-serif font. The curved shape in the square resembles a road or path.
Convaid Product Inc. Model: Trekker Manual Wheelchairs 510(k) Summary Of Safety and Efficacy Revised 8/27/2014
A. General Information
| 1. | Submitter Name: | Convaid Products Inc. |
|---|---|---|
| 2. | Address: | 2830 California St. |
| Torrance CA, 90503 | ||
| 3. | Telephone: | 310-618-0111 |
| Fax: 310-618-2172 | ||
| 4. | Contact Person: | Donald Griggs |
| Quality Assurance Manager | ||
| 5. | Registration Number: | 2022883 |
| 6. | Date Prepared: | 03/27/2014 |
B. Device
| 1. | Device Trade Name: | Trekker TR12, TR14 &
Trekker Transit TR12T, TR14T |
|----|-----------------------------|------------------------------------------------------|
| 2. | Common/Generic Name: | Wheelchair-Manual |
| 3. | Device Classification Name: | Mechanical Wheelchair |
| 4. | Registration Number: | 2022883 |
| 5. | Product Code: | IOR |
| 6. | Device Classification | Class 1 |
| 7. | Regulatory Number: | 890.3850 |
C. Identification of Legally Marketed Devices
- Manufacture Name: Convaid products Inc. 1.
-
- Name: Champ
-
- K Number: K120501 10/20/2012 Date Cleared: 4.
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Image /page/5/Picture/0 description: The image contains the logo for Convaid. The logo consists of a blue square with a white curved shape inside, followed by the word "Convaid" in black, sans-serif font. The curved shape in the blue square resembles a stylized wave or path.
D. Description of the device
The Trekker TR12, TR12T and TR14, TR14T are attendant propelled manual wheelchairs. They are lightweight compact folding wheelchairs with tubular 6061 aluminum frames with removable seating modules for easy transport and stowage. The seating module is also reversible to allow the caregiver the option to observe the user during use.
Front small casters for steering and maneuverability and larger wheels in the rear. A tilt function for pressure relief and the recline function provide adjustability for the lower extremities.
Foot operated wheel locks provide easy operation.
Positioning options include H-harness, two point seat belt, three point seat belt with crotch pad additional non-positioning accessories include under seat storage basket, adjustable I.V. Pole.
Trekker transit option TR12T and TR14T transit models are identical to the TR12 and TR14 except for the factory installation of four (4) tie-down anchors and required labeling. They meet the requirements for use as seating in motor vehicles when used in conjunction with the vehicle supplied four (4) wheelchair tie-down system that attaches to the four (4) transport anchors on the wheelchair and a three (3) point occupant restraint system in accordance with SAE J2249 or WC4:2012 section 18 that creates the shoulder and lap belt combination that attaches to the wheelchair or to the floor of the vehicle.
E. Intended Use
The Convaid Trekker models are manual wheelchairs; there intended use is to provide mobility to persons with disabilities who are partially or permanently non-ambulatory and limited to a sitting position.
In addition the Trekker Transit models TR12T and TR14T comply with the requirements of RESNA WC4:2012-section 19 Wheelchairs used as seats in motor vehicles.
Technological Characteristics Summary F.
The Convaid Trekker is a standard manual folding aluminum frame wheelchair. The frame is made to be durable, lightweight and compact folding. The Trekker is an attendant propelled device with a removable seating module for easy stowage and transport. The seating module can be used facing in either direction this poses no additional risk as supported by the stability testing performed. Single piece height adjustable push handle for attendant comfort. Tilt and recline functions for pressure relief and comfort.
The transit models can be used as seating in a motor vehicle per RESNA WC4:2012 section 19.
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Image /page/6/Picture/0 description: The image shows the logo for Convaid. The logo consists of a blue square with a white curved shape inside, followed by the word "Convaid" in black sans-serif font. The blue square is on the left side of the logo, and the word "Convaid" is on the right side.
G: Comparison of device characteristics to predicate
The Trekker models have similar characteristics (see comparison chart pages 4 and 5 this section), technology and are constructed of identical materials as the Convaid Champ models.
The Trekker and the Champ have lightweight tubular powder coated 6061 aluminum frames. They are designed to be compact folding for easy stowage and transport. The Trekker and the Champ models have removable seating modules in addition the Trekker's seating module can be used facing in either direction and the Champ models do not have this ability. The reversible seat module poses no new safety issues. The Trekker models fold using pivoting push handles tubes and side brackets and the Champ models uses a center cross brace to allow it to fold. These are both common designs in use today on folding non-rigid wheelchairs and the difference poses no additional risk. Both the Trekker and the Champ have tilt and recline functions, both have similar elevating height adjustable foot supports, headrest and push handle (optional on the Champ). Both having the same positioning options available H-harness, two or three point lap belts, foot positioners and depth adiustable crotch pad. The Trekker has two additional options available an I.V. Pole and an under seat storage basket, these options pose no additional risks.
The Champ models have a ten (10) inch seat width and the Trekker models have a twelve (12) and fourteen (14) inch seat widths. The different sizes are designed to accommodate different ranges of users and pose no additional risks as indicated by testing to RESNA wheelchair standards.
The Champ models have the availability of self or attendant propulsion with the optional push handle where as the Trekker models are only attendant propelled. This single function poses no additional risk to the device. They both have small casters in the front for steering and maneuverability and larger wheels in the back. The attendant propelled operating characteristics and maneuverability is equivalent and is recommended for indoor or outdoor use on flat firm terrain.
The optional transit models designated with a "T" after the model number can be used as seating in a motor vehicle per ANSI-RESNA WC Vol-1-section 19:2000 Champ or WC4:2012 section 19 for the Trekker. Both the Trekker optional transit models TR12T, TR14T and the Champ CH10T optional transit model have the addition of four (4) tiedown anchors factory installed to the standard units, no other structural modification are performed. They were tested with an approved four (4) wheelchair tie-down system and a three (3) point occupant restraint system in accordance with SAE J2249or WC4:2012 section 18.
Both the Trekker and the Champ have the same intended use to provide mobility to persons with physical disabilities who are partially or permanently non-ambulatory and limited to a sitting position and as use as seating in motor vehicles.
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Image /page/7/Picture/0 description: The image shows the logo for Convaid. The logo consists of a blue square with a white curved line inside, followed by the word "Convaid" in black sans-serif font. The logo is simple and modern, with a clean design.
| | TR12 | TR12T | TR14 | TR14T | CH10 | CH10T | Comparison to
Predicate |
|------------------------------------------------------------|-----------------------------|-----------------------------|------------------------------|------------------------------|------------------------------|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Seat width | 12 " | 12 " | 14" | 14" | 10" | 10" | Similar no impact
on safety and
effectiveness |
| Seat depth | 6" to 12" | 6" to 12" | 9" to 16" | 9" to 16" | 8" to 10" | 8" to 10" | Same as above |
| Seat to back
height | 15" to 21" | 15" to 21" | 17" to 26" | 17" to 26" | 11
& 15" | 11
& 15" | Additional height
poses no
additional risk |
| Seat to footrest | 6" to 14" | 6" to 14" | 6" to 14" | 6" to 14" | 7.5"
to 12" | 7.5"
to 12" | Similar in range
no impact on
safety and
effectiveness |
| Footplate 1 piece
adjustable | +/- 15° | +/- 15° | +/- 15° | +/- 15° | -20° +10° | -20° +10° | Same as above |
| Seat to floor | 16" – 25" | 16" – 25" | 17" – 25" | 17" – 25" | 15" | 15" | Relative to users
size, testing show
no effect on safety
or efficacy |
| Recline/Seat to
back angle | 80° to 100° | 80° to 100° | 80° to 100° | 80° to
100° | 80° to
120° | 80°
to 120° | testing shows no
effect on safety or
effectiveness |
| Optional recline/
seat to back
angle | 80° to 170° | 80° to 170° | 80° to 170° | 80° to
170° | N/A | N/A | RESNA WC1-1
Static stability
testing shows no
effect on safety or
effectiveness
- Testing was
performed in a
stationary position |
| Tilt adjustment | -5° to 45° | -5° to 45° | -5° to 45° | -5° to 45° | 0° to 45° | 0° to 45° | Similar no
impact on safety
and effectiveness |
| Headrest Support | 6" | 6" | 6" | 6" | 4" to 8" | 4" to 8" | Same as above |
| Chair weight | 32 lbs | 32 lbs | 33 lbs | 33 lbs | 26 lbs | 26 lbs | Weight range is
size dependant
test results are
satisfactory |
| Chair width | 24.3" | 24.3" | 26.3" | 26.3" | 22" | 22" | Similar no
impact on safety
and effectiveness |
| Overall height | 37.5" | 37.5" | 37.5" | 37.5" | 38" | 38" | Similar no impact
on safety and
effectiveness |
| Overall length | 42" | 42" | 42" | 42" | 26" | 26" | Trekkers larger
length would
enhance stability |
| Weight capacity | 75 lbs
Std or
transit | 75 lbs
Std or
transit | 110 lbs
Std
or transit | 110 lbs
Std
or transit | 66 lbs.
Std or
transit | 66 lbs.
Std or
transit | Relative to users
size, testing show
no effect on safety
or effectiveness |
| Tilt in space | Single
mech.
lock | Single
mech.
lock | Single
mech.
lock | Single
mech.
lock | Single
mech.
lock | Single
mech.
lock | Same
functionality |
| | TR12 | TR12T | TR14 | TR14T | CH10 | CH10T | Comparison to
Predicate |
| Removable seating
module with seat
and back cushions | Yes | Yes | Yes | Yes | Yes | Yes | All have
removable
seating modules |
| Transit Option | No | Yes | No | Yes | No | Yes | Tested to WC
section 19
requirements |
| Frame tubular 6061
Aluminum | Yes | Yes | Yes | Yes | Yes | Yes | Same materials |
| Upholstery and
fabric
accessories | Same | Same | Same | Same | Same | Same | Identical fabrics
on all models |
| Wheel locks | Foot
actuated | Foot
actuated | Foot
actuated | Foot
actuated | Hand
toggle | Hand
toggle | Tested and
results show no
impact on safety
and effectiveness |
| Footplate | One
piece | One
piece | One
piece | One piece | One
piece | One
piece | Similar no
impact on safety
and effectiveness |
| Frame coating | Powder
coated | Powder
coated | Powder
coated | Powder
coated | Powder
coated | Powder
coated | Identical coating
used on all
models |
| Camber | N/A | N/A | N/A | N/A | 8° non-
Adjust-
able | 8° non-
Adjust-
able | Camber is only
on self propelled
devices no
impact on safety
and effectiveness |
| Front caster
diameter | 7.5 | | | | | | |
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Image /page/8/Picture/0 description: The image shows the logo for Convaid. The logo consists of a blue square with a white curved shape inside, followed by the word "Convaid" in black font. The wordmark is simple and modern.
Comparison Table Continued
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Image /page/9/Picture/0 description: The image shows the logo for Convaid. The logo consists of a blue square with a white curved shape inside, followed by the word "Convaid" in black. The word "Convaid" is written in a simple, sans-serif font. The logo is clean and modern, with a focus on simplicity and readability.
H: Non-Clinical Testing
Convaid's Trekker manual wheelchairs meet the applicable performance requirements as specified below;
ANSI-RESNA WC 1:2009-1 ANSI-RESNA WC 1:2009-5 ANSI-RESNA WC 1:2009-7 ANSI-RESNA WC 1:2009-8 ANSI-RESNA WC 1:2009-11 ANSI-RESNA WC 1:2009-13 ANSI-RESNA WC 1:2009-15 ANSI-RESNA WC 1:2009-16 ANSI-RESNA WC 1:2009-22 ANSI-RESNA WC 1:2009-26 ANSI-RESNA WC 2:2009-3 RESNA WC4:2012 section 19 (Trekker) WCVol.1 section 19:2000 (Champ) ISO 10993-5
l: Storage / Shelf life:
The Trekker model wheelchairs are built to order so storage/shelf life concerns would only occur after delivery to the purchaser.
Storage procedures are covered in the user's guide "Unit should be stored in a clean, dry area and avoid extended exposure to moisture. After extended storage periods and before use the entire chair needs to be serviced". Owner should reference user's guide maintenance section and chart for periodic maintenance and inspections.
J: Biocompatibility:
Type of contact: Skin Contact duration category C >30 days.
Patient: Contact of intact skin of hands and arms with the following materials. Cordura fabric, spacer fabric, transient contact with intact skin of the hands, neck and feet with ballistic nylon and aluminum frame.
Conclusion: Trekkers use the identical patient contacting materials used in the predicate devices Convaid Champs and does not raise any new biocompatibility issues.
K: Safety and Effectiveness:
The Trekker series and the Champ series share technology, design, performance and construction materials and does not raise any new issues of safety and effectiveness.
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Image /page/10/Picture/0 description: The image contains the logo for Convaid. The logo consists of a blue square with a white curved line inside, followed by the word "Convaid" in black. The word "Convaid" is written in a simple, sans-serif font.
L: Conclusion:
The Trekker TR12, TR14 and Trekker transit TR12T and TR14T wheelchair series shares performance, design technology and intended use with the predicate devices Convaid Champ CH10 and Champ transit CH10T cleared on 10/20/12 on K120501. There are no significant differences between the Trekker transit wheelchairs and the Champ and Champ transit wheelchair that would raise any new issues of safety and effectiveness therefore the Trekker and Trekker transit wheelchair series are substantially equivalent to the predicate devices.