The Invacare® Tracer Manual Wheelchair, Invacare® Tracer® SX5 Manual Wheelchair, Invacare Tracer SX5 Recliner Manual Wheelchair, and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair are intended to provide mobility to persons limited to a sitting position.

Device Description

The Invacare® Tracer® SX5 Manual Wheelchair is intended to provide mobility to persons who may be restricted to a sitting position. The manual wheelchair is intended for ongoing daily use. The models offer a wide range of customization which allows for a better fit for the end user resulting in comfort, lightweight, easier propelling, transferring, and smooth ride. The manual wheelchair is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.

The Invacare® Tracer® SX5 Recliner Manual Wheelchair is a Tracer SX5 model with the addition of a recline feature. This recliner model incorporates a mechanism that allows the backrest to recline in angles from 90° to 180°. Both models of the chair have a weight capacity of 250 to 300 lbs. depending on the seat width. Both models also come with an anti-tipper device to ensure the chair remains stable while in use.

The Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair has the same intended use as the Invacare® Tracer® SX5 Manual Wheelchair. However, the Tracer IV does not come with a recliner model and has a higher weight capacity of 350 lbs. depending on the configuration. Both models of Tracer IV chairs come with a push-to-lock or pull-to-lock feature to engage and disengage the wheel locks. Both models also come with anti-tippers that allow clearance of 1.5 to 2 inches.

AI/ML Overview

The provided text describes the 510(k) premarket notification for three manual wheelchair models by Invacare Corporation: Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer SX5 Recline Manual Wheelchair, and Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair. The document focuses on demonstrating substantial equivalence to predicate and reference devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the context of an AI/algorithm-based medical device.

Therefore, most of the requested information regarding acceptance criteria, study design for AI devices, sample sizes, expert involvement, ground truth establishment, MRMC studies, and standalone performance is not applicable to this document. This is because the submission is for a mechanical medical device (manual wheelchairs), not a software or AI-driven device.

However, I can extract the relevant information from the document that pertains to the types of "performance testing" conducted to demonstrate substantial equivalence for these mechanical devices.

Here's a breakdown based on the document's content:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it states that "Verification Testing demonstrated that the subject Invacare® Tracer® SX5 Manual and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual are substantially equivalent to the marketed predicate and reference devices." This implies that the devices met the performance standards outlined in the referenced ANSI/RESNA and ISO standards. The performance reporting is implicit; the tests were successfully passed, indicating conformance with the standards.

Test Performed (Standard Referenced)	Implied Acceptance Criteria (Based on passing the standard)	Reported Device Performance
ANSI / RESNA WC/Volume 1 2009, Section 1: Determination of Static Stability	Must meet the static stability requirements defined in the standard.	Demonstrated substantial equivalence; tests were successful.
ANSI / RESNA WC/Volume 1 2009, Section 3: Determination of Effectiveness of Brakes	Brakes must meet the effectiveness requirements defined in the standard.	Demonstrated substantial equivalence; tests were successful.
ANSI / RESNA WC/Volume 1 2009, Section 5: Determination of Dimensions, Mass and Maneuvering Space	Dimensions, mass, and maneuvering space must conform to the standard's specifications or be within acceptable variance from predicate.	Demonstrated substantial equivalence; tests were successful (implicitly, also supported by "design characteristics comparison").
ANSI / RESNA WC/Volume 1 - 2009, Section 7: Measurement of Seating and Wheel Dimensions	Seating and wheel dimensions must conform to the standard's specifications or be within acceptable variance from predicate.	Demonstrated substantial equivalence; tests were successful (implicitly).
ANSI / RESNA WC/Volume 1 2009, Section 8: Static, Impact and Fatigue Strengths Tests	Must withstand static, impact, and fatigue stresses as defined in the standard.	Demonstrated substantial equivalence; tests were successful.
RESNA WC-1:2009 Section 11: Test Dummies	(This section concerns the test apparatus, not a device performance metric itself. Implies proper use of test dummies.)	N/A (Methodology, not a direct performance outcome)
RESNA WC-1:2009 Section 13: Determination of Coefficient of Friction of Test Surfaces	(This section concerns the test environment, not a device performance metric itself. Implies proper control of test surfaces.)	N/A (Methodology, not a direct performance outcome)
ANSI / RESNA WC/Volume 1 2009, Section 15: Requirements for Information Disclosure, Documentation and Labeling	Information disclosure, documentation, and labeling must comply with the standard.	Demonstrated substantial equivalence; tests were successful.
CAL117:2013, Section 1: Flammability Testing	Must meet flammability resistance requirements defined in the standard.	Tests were successful.
ISO 8191-1:1987 & 8191-2:1988: Flammability Testing	Must meet flammability resistance requirements defined in the standard.	Tests were successful.
Biocompatibility (AAMI / ANSI / ISO 10993-5:2009 & 10993-10:2010)	Must demonstrate acceptable levels of cytotoxicity and skin irritation.	Tests were successful.

2. Sample sizes used for the test set and the data provenance:

Test Set Sample Size: The document does not specify the number of individual wheelchairs tested. It refers to "the subject Invacare® Tracer Manual Wheelchairs" and "the subject Invacare® Tracer® SX5 Manual and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual," suggesting representative samples were tested as per the standards. Specific quantities are not provided.
Data Provenance: The testing was "Non-clinical laboratory testing" conducted on the subject devices. Location of testing and whether it was retrospective or prospective is not explicitly stated, but for a mechanical device undergoing performance testing, it would inherently be prospective testing of new models.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. The "ground truth" for mechanical performance tests like these is established by adherence to recognized international and national standards (e.g., ANSI/RESNA, ISO) and the physical properties and performance characteristics of the devices themselves, measured by accredited laboratories and engineers. It does not involve expert consensus in the way an AI diagnostic tool's ground truth would.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in subjective assessments (e.g., medical image interpretation). Mechanical performance testing relies on objective measurements against established engineering 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:

This is not applicable. MRMC studies are specific to AI-assisted diagnostic or interpretative tasks involving human readers. This submission is for mechanical manual wheelchairs.

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

This is not applicable. This refers to an AI algorithm's performance independent of human input. The device is a mechanical wheelchair.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for these mechanical devices is established through adherence to recognized national and international performance standards (ANSI/RESNA, ISO, CAL117) via physical and material testing. For biocompatibility, the ground truth is established by the results of cytotoxicity and skin irritation tests conforming to ISO standards.

8. The sample size for the training set:

This is not applicable. "Training set" refers to data used to train machine learning models. This is a mechanical device.

9. How the ground truth for the training set was established:

This is not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 17, 2017

Invacare Corporation Elijah Wreh Regulatory Affairs Manager (pre-market) One Invacare Way Elyria, Ohio 44035

Re: K162621

Trade/Device Name: Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer SX5 Recline Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair

Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: October 5, 2016 Received: October 6, 2016

Dear Elijah Wreh:

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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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as set forth in the quality systems (OS) 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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/ResourcesforYou/Industry/default.htm. 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.

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,

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for

Carlos L. 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) K162621

Device Name

Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer SX5 Recliner Manual Wheelchair, Invacare Tracer IV Heavy Duty/extra Wide Manual Wheelchair

Indications for Use (Describe)

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

SUBMITTER:	Invacare CorporationOne Invacare WayElyria, OH 44035
	Phone: (440) 329-6840Email: ewreh@invacare.com
CONTACT PERSON:	Elijah N. WrehRegulatory Affairs Manager (Pre-Market)
MANUFACTURER:	INVAMEX S.DE R.L. DE C.V.Avenida El Puente S/NParque Industrial El Puente ManimexReynosa Tamaulipas, Mexico C.P. 88783
Date Prepared:	April 17, 2017
DEVICEName of Devices:	Invacare Tracer SX5 Manual WheelchairInvacare Tracer SX5 Recline Manual WheelchairInvacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair
Common or Usual Name:Classification Name:	Wheelchair, MechanicalMechanical Wheelchair 21 CFR §890.3850
Regulatory Class:	I
Product Code:	IOR: Wheelchair, Mechanical
Regulation Description:	Mechanical Wheelchair
PREDICATE DEVICE:	Tracer Series Mechanical Wheelchairs (K935398)
REFERENCE DEVICE:	Ride Lite 9000 Series Wheelchair (K881951)

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DEVICE DESCRIPTION

. Invacare Tracer SX5 Manual Wheelchair
- o Seat Width 14" to 18" 250 lbs. (114 Kg)
- o Seat width 20" to 22" 300 lbs. (136 Kg)
Invacare Tracer SX5 Recline Manual Wheelchair .
- o Seat Width 14" to 18" 250 lbs. (114 Kg)
- o Seat width 20" to 22" 300 lbs. (136 Kg)
Invacare Tracer IV & Heavy Duty Manual Wheelchair . o Weight capacity at 350 lbs. and 450 lbs.
Tipper aid ●
Cane holder
Anti-theft device
Non-folding device
O2 holder ●
Wheel lock extension ●
IV rod telescopic fixed back .

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INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE and REFERENCE DEVICES

The device comparison showed that the subject devices are substantially equivalent in intended use, design, materials, and operational principles to the previously cleared Tracer Series Mechanical Wheelchairs (K935398) to provide mobility to persons limited to a sitting position.

BASIS OF SUBSTANTIAL EQUIVALENCE

The substantial equivalence of the subject device was determined as per the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" and the technological characteristics which include materials, design, energy source, and other device features, as defined in section 513(i)(1)(B) of the FD&C Act and 21 CFR 807.100(b)(2)(ii)(A).

The subject device components are as safe and effective as the predicate and reference devices and do not raise different questions of safety and effectiveness.

The major frame components for the subject Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair and the previously cleared Tracer Series Manual Wheelchairs (K935398) are the same. The data generated from the subject Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair test report supports a finding of substantial equivalence in regards to the device comparison, dimensional analysis, device specifications, design characteristics and to provide mobility to persons limited to a sitting position.

The difference in weight capacity between the subject Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair and the previously cleared Tracer Series Manual Wheelchairs (K935398) do not raise no new issues of safety or effectiveness.

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In conclusion, the performance testing, device comparison, and dimensional analysis demonstrates that the subject device components are substantially equivalent to the predicate and reference devices in regards to static stability, effectiveness of brakes, dimensions, mass and maneuvering space, measurement of seating and wheel dimensions, static impact and fatigue strength, coefficient of friction, information disclosures, documentation and labeling.

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Design Characteristics Comparison – Invacare® Tracer® SX5 Manual Wheelchair

Device	Invacare® Tracer® SX5 Manual Wheelchair	Tracer Series Manual Wheelchairs
510(k) Number	Subject DevicesPending Submission (K162621)	Predicate Device(K935398)
Intended Use	The Invacare® Tracer® Manual Wheelchair is intended to provide mobility to persons limited to a sitting position.	To provide mobility to persons who may be restricted to a sitting position.
Indications for Use	The Invacare® Tracer® SX5 Manual Wheelchair and Invacare®Tracer® SX5 Recliner Manual Wheelchair are intended to providemobility to persons limited to a sitting position.	Persons who may be restricted to a sitting position.
Design	Tracer SX5(Subject Device)	Tracer Series Manual Wheelchairs(K935398)
Weight Limit	250 lbs.300 lbs.	250 lbs.
Seat Width 14" to 18"Seat Width 20" to 22"	X-design	X-design
Cross-brace Configuration	14", 16", 18", 20" or 22 "	16.5 ", 18 "
Seat Width	14" to 18" with the weight limitation is 250 lbs.20" to 22" with the weight limitation is 300 lbs.	14" to 18"
Seat Depth	16" to 18"	13", 14", 15", 16", 17", 18", 19", 20", 21" or 22"
Back Style	Fixed	Fixed
Arm Types	Fixed or adjustable height; desk or full length; removable	Permanent and/or Removable
Anti-Tippers	Optional	Optional
Wheel Locks	Push-to-lock and pull-to-lock	Push to lock
Rear Wheel Sizes	20", 22", 24 "	20", 22", 24 " composite
Caster Sizes	6 " – 8"	6 " – 8"
Front riggings	Swing away	Swing away

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Device	Invacare Tracer SX5 Recliner Manual Wheelchair	Ride Lite 9000 Series Wheelchair
510(k) Number	Subject Device(K162621)	Reference Device(K881951)
Intended Use	The Invacare® Tracer Manual Wheelchair is intended to providemobility to persons limited to a sitting position.	The Ride Lite 9000 Series Wheelchair is intended to provide mobility to persons limitedto a sitting position.
Indications for Use	The Invacare® Tracer® SX5 Manual Wheelchair and Invacare®Tracer® SX5 Recliner Manual Wheelchair are intended toprovide mobility to persons limited to a sitting position	The Ride Lite 9000 Series Wheelchair is indicated to provide mobility to person ages 12and up (adolescents and adults) with a weight capacity of 350 lb. depending on the seatwidth.
Design
Weight Limit	250 lbs.300 lbs.	350 lb.
Seat Width	16" and 18"	14" and 18"
Recline Feature	Reclining	Reclining
Cross-brace Configuration	X-design	X-design
Seat Depth	16" and 18"	16", 17" and 18"
Back Style	Reclining (5° – 78° vertical measurement)	Reclining (5° – 78° vertical measurement)
Arm Types	Fixed or adjustable height; desk or full length; removable	Fixed or adjustable height; desk or full length; removable
Anti-Tippers	Required	Required
Wheel Locks	Push-to-lock and pull-to-lock	Push-to-lock and pull-to-lock
Rear Wheel Sizes	20", 22", 24"	20", 22", 24"
Caster Sizes	6" – 8"	6" – 8"
Front riggings	Swing away	Swing away

Design Characteristics Comparison – Invacare Tracer SX5 Recliner Manual Wheelchair

Note: The reference device is used for the recline feature and technical characteristics comparison.

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Device	Invacare® Tracer IV® Heavy Duty/Extra Wide ManualWheelchair	Tracer Series Manual Wheelchairs
510(k) Number	Subject DevicePending Submission (K162621)	Primary Predicate Device(K935398)
Intended Use	The Invacare® Tracer® Manual Wheelchair is intended to providemobility to persons limited to a sitting position.	To provide mobility to persons who may be restricted to a sitting position.
Indications for Use	The Invacare® Tracer® IV Manual Wheelchair and Invacare®Tracer® IV Heavy Duty/Extra Wide Manual Wheelchair are intendedto provide mobility to persons limited to a sitting position.	Persons who may be restricted to a sitting position.
Design
Weight Limit	350lbs.450 lbs.	250 lbs.
Cross-brace Configuration	X-design	X-design
Seat Width	18", 20", 22" or 24"	16.5", 18"
Seat Depth	18" and 20"	16", 16"
Back Style	Fixed	Fixed
Arm Types	Fixed or adjustable height; desk or full length; removable	Permanent and/or Removable
Anti-Tippers	Optional	Optional
Wheel Locks	Push to Lock (Adult), Pull to Lock (Hemi)	Push to lock
Rear Wheel Sizes	24" Composite; 24" pneumatic flat free insert	20", 22", 24" composite
Caster Sizes	8 x 1 $1/4$ "Urethane8 x 1 $3/4$ "Semi Pneumatic	6"- 8" *
Front riggings	Swing away	Swing away

Design Characteristics Comparison – Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair

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PERFORMANCE DATA

Non-Clinical Test

Non-clinical laboratory testing was performed on the subject Invacare® Tracer Manual Wheelchairs to determine substantial equivalence. The following testing was performed:

ANSI / RESNA WC/Volume 1 2009, Section 1: Determination of Static Stability .
ANSI / RESNA WC/Volume 1 2009, Section 3: Determination of Effectiveness of . Brakes
ANSI / RESNA WC/Volume 1 2009, Section 5: Determination of Dimensions, Mass . and Maneuvering Space
. ANSI / RESNA WC/Volume 1 - 2009, Section 7: Measurement of Seating and Wheel Dimensions
ANSI / RESNA WC/Volume 1 2009, Section 8: Static, Impact and Fatigue Strengths . Tests
RESNA WC-1:2009 Section 11: Test Dummies .
RESNA WC-1:2009 Section 13: Determination of Coefficient of Friction of Test . Surfaces
ANSI / RESNA WC/Volume 1 2009, Section 15: Requirements for Information . Disclosure, Documentation and Labeling
CAL117:2013, Section 1: Flammability Testing .
ISO 8191-1:1987 & 8191-2:1988: Flammability Testing .

Verification Testing demonstrated that the subject Invacare® Tracer® SX5 Manual and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual are substantially equivalent to the marketed predicate and reference devices.

Biocompatibility Testing

The biocompatibility evaluation for the subject Invacare® Tracer® SX5 Manual and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual were conducted in accordance with the FDA Blue Book Memorandum #G95 – 1 "Use of International Standard ISO – 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"' May 1, 1995, and International Standard ISO 10993 - 1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

AAMI / ANSI / ISO 10993-5:2009, Biological Evaluation of Medical Devices Part 5: Tests for in vitro Cytotoxicity

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AAMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for Skin Irritation

Animal Study

Animal testing was not required for this submission.

Clinical Testing

Clinical testing was not required for this submission.

CONCLUSIONS

The subject devices have the same intended use and similar technological characteristics as the predicate and reference devices. Design Verification Testing support the safety and performance of the subject devices and demonstrate that the subject devices should perform as intended in the specified use conditions. Therefore, the subject Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer SX5 Recline Manual Wheelchair, and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair are substantially equivalent to the predicate and reference devices identified throughout this submission.

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).