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.

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.

AI/ML Overview

This document describes the Convaid Trekker manual wheelchairs (TR12, TR14, TR12T, TR14T) and their substantial equivalence to the predicate device, the Convaid Champ (CH10, CH10T). Since this is a 510(k) premarket notification for a Class I device, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving efficacy through clinical studies for a novel device. Therefore, the information provided below will reflect this specific regulatory context.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Convaid Trekker wheelchairs are defined by their compliance with various industry standards, primarily from ANSI-RESNA and ISO. The "reported device performance" is essentially the statement of compliance to these standards and the determination of substantial equivalence.

Acceptance Criteria (Standards Met)	Reported Device Performance (Claimed Compliance)
ANSI-RESNA WC 1:2009-1 (likely for general wheelchair performance)	Convaid's Trekker manual wheelchairs meet the applicable performance requirements as specified.
ANSI-RESNA WC 1:2009-5 (likely for general wheelchair performance)	Convaid's Trekker manual wheelchairs meet the applicable performance requirements as specified.
ANSI-RESNA WC 1:2009-7 (likely for general wheelchair performance)	Convaid's Trekker manual wheelchairs meet the applicable performance requirements as specified.
ANSI-RESNA WC 1:2009-8 (likely for general wheelchair performance)	Convaid's Trekker manual wheelchairs meet the applicable performance requirements as specified.
ANSI-RESNA WC 1:2009-11 (likely for general wheelchair performance)	Convaid's Trekker manual wheelchairs meet the applicable performance requirements as specified.
ANSI-RESNA WC 1:2009-13 (likely for general wheelchair performance)	Convaid's Trekker manual wheelchairs meet the applicable performance requirements as specified.
ANSI-RESNA WC 1:2009-15 (likely for general wheelchair performance)	Convaid's Trekker manual wheelchairs meet the applicable performance requirements as specified.
ANSI-RESNA WC 1:2009-16 (likely for general wheelchair performance)	Convaid's Trekker manual wheelchairs meet the applicable performance requirements as specified.
ANSI-RESNA WC 1:2009-22 (likely for general wheelchair performance)	Convaid's Trekker manual wheelchairs meet the applicable performance requirements as specified.
ANSI-RESNA WC 1:2009-26 (likely for general wheelchair performance)	Convaid's Trekker manual wheelchairs meet the applicable performance requirements as specified.
ANSI-RESNA WC 2:2009-3 (likely for general wheelchair performance)	Convaid's Trekker manual wheelchairs meet the applicable performance requirements as specified.
RESNA WC4:2012 section 19 (for wheelchairs used as seats in motor vehicles - Trekker models)	Trekker models TR12T and TR14T comply with these requirements.
WCVol.1 section 19:2000 (for wheelchairs used as seats in motor vehicles - Champ models)	(Predicate device compliance, relevant for comparison)
ISO 10993-5 (Biocompatibility - Cytotoxicity)	Trekker device materials are identical to predicate devices and raise no new biocompatibility issues.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a "sample size" in terms of number of manufactured units tested. Instead, it states that Convaid's Trekker manual wheelchairs "meet the applicable performance requirements as specified below," referring to the list of ANSI-RESNA and ISO standards. This implies that testing was conducted on representative units of the Trekker models to demonstrate compliance with these engineering and safety standards. The specific number of units tested per standard is not detailed in this summary.
Data Provenance: The data provenance is from non-clinical testing conducted by the manufacturer, Convaid Products Inc., to demonstrate compliance with recognized industry standards. The country of origin of the data is implicitly the United States (where Convaid is based and where the FDA evaluates the submission). The testing is prospective in the sense that it was performed specifically for this 510(k) submission to demonstrate compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to a 510(k) submission for a Class I mechanical device like a wheelchair. "Ground truth" in this context refers to compliance with established engineering and safety standards, which is typically validated through objective laboratory testing and measurements. Expert consensus or clinical adjudication is not typically used to establish ground truth for adherence to these types of performance standards. The "experts" involved would be qualified test engineers and technicians performing the standard-defined tests.

4. Adjudication Method for the Test Set

Not applicable in the context of demonstrating compliance with engineering and safety standards. The "adjudication" is essentially the testing laboratory reporting whether the device passed or failed each specific requirement of the cited standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-powered diagnostic or assistive device. It is a mechanical wheelchair.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical wheelchair, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's acceptance is adherence to the technical, safety, and performance requirements specified in the following industry standards:

ANSI-RESNA WC 1:2009 series (Sections 1, 5, 7, 8, 11, 13, 15, 16, 22, 26) - These are likely standards related to general wheelchair performance, stability, durability, strength, and other mechanical aspects.
ANSI-RESNA WC 2:2009-3 (likely for pediatric or specific user group wheelchairs)
RESNA WC4:2012 section 19 - Specifically for wheelchairs used as seats in motor vehicles (for the Trekker Transit models).
WCVol.1 section 19:2000 - The equivalent standard for the predicate Champ Transit models.
ISO 10993-5 (Biocompatibility) - Specifically for in vitro cytotoxicity testing of patient-contacting materials.

The "ground truth" is verified by objective measurements and tests according to the methodology outlined in these standards.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and there is no "training set" in the machine learning sense. The design and manufacturing processes are refined through engineering development and testing, not algorithmic training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set." The design and validation of the device are based on engineering principles and compliance with established standards, which serve as the "ground truth" for its safety and performance.

Summary

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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

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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

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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)

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)

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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:	310-618-0111Fax: 310-618-2172
4.	Contact Person:	Donald GriggsQuality 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.
1. Name: Champ
1. K Number: K120501 10/20/2012 Date Cleared: 4.

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D. Description of the device

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.

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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	TR12	TR12T	TR14	TR14T	CH10	CH10T	Comparison toPredicate
Seat width	12 "	12 "	14"	14"	10"	10"	Similar no impacton safety andeffectiveness
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 backheight	15" to 21"	15" to 21"	17" to 26"	17" to 26"	11& 15"	11& 15"	Additional heightposes noadditional 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 rangeno impact onsafety andeffectiveness
Footplate 1 pieceadjustable	+/- 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 userssize, testing showno effect on safetyor efficacy
Recline/Seat toback angle	80° to 100°	80° to 100°	80° to 100°	80° to100°	80° to120°	80°to 120°	testing shows noeffect on safety oreffectiveness
Optional recline/seat to backangle	80° to 170°	80° to 170°	80° to 170°	80° to170°	N/A	N/A	RESNA WC1-1Static stabilitytesting shows noeffect on safety oreffectiveness* Testing wasperformed in astationary position
Tilt adjustment	-5° to 45°	-5° to 45°	-5° to 45°	-5° to 45°	0° to 45°	0° to 45°	Similar noimpact on safetyand 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 issize dependanttest results aresatisfactory
Chair width	24.3"	24.3"	26.3"	26.3"	22"	22"	Similar noimpact on safetyand effectiveness
Overall height	37.5"	37.5"	37.5"	37.5"	38"	38"	Similar no impacton safety andeffectiveness
Overall length	42"	42"	42"	42"	26"	26"	Trekkers largerlength wouldenhance stability
Weight capacity	75 lbsStd ortransit	75 lbsStd ortransit	110 lbsStdor transit	110 lbsStdor transit	66 lbs.Std ortransit	66 lbs.Std ortransit	Relative to userssize, testing showno effect on safetyor effectiveness
Tilt in space	Singlemech.lock	Singlemech.lock	Singlemech.lock	Singlemech.lock	Singlemech.lock	Singlemech.lock	Samefunctionality
	TR12	TR12T	TR14	TR14T	CH10	CH10T	Comparison toPredicate
Removable seatingmodule with seatand back cushions	Yes	Yes	Yes	Yes	Yes	Yes	All haveremovableseating modules
Transit Option	No	Yes	No	Yes	No	Yes	Tested to WCsection 19requirements
Frame tubular 6061Aluminum	Yes	Yes	Yes	Yes	Yes	Yes	Same materials
Upholstery andfabricaccessories	Same	Same	Same	Same	Same	Same	Identical fabricson all models
Wheel locks	Footactuated	Footactuated	Footactuated	Footactuated	Handtoggle	Handtoggle	Tested andresults show noimpact on safetyand effectiveness
Footplate	Onepiece	Onepiece	Onepiece	One piece	Onepiece	Onepiece	Similar noimpact on safetyand effectiveness
Frame coating	Powdercoated	Powdercoated	Powdercoated	Powdercoated	Powdercoated	Powdercoated	Identical coatingused on allmodels
Camber	N/A	N/A	N/A	N/A	8° non-Adjust-able	8° non-Adjust-able	Camber is onlyon self propelleddevices noimpact on safetyand effectiveness
Front casterdiameter	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.

Regulation Number and Section

§ 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).