KARMA DISCOVERY, MODEL KP40

• K Number: K014127
• Device Name: KARMA DISCOVERY, MODEL KP40
• Manufacturer: VESTIL MANUFACTURING CORP.
• Date Cleared: 2002-03-15 ( 88 days)
• Product Code: ITI
• Regulation Number: 890.3860

Intended Use

The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.

Device Description

The Discovery power wheelchair is a battery powered, motorized mobility vehicle. The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair. The Discovery is designed to be durable, dependable, sporty and aesthetically appealing while being economically priced.

Predicate Devices

K852811

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard power wheelchair and does not mention any AI or ML capabilities.

Therapeutic

No.
A power wheelchair provides mobility assistance, which is distinct from direct therapeutic treatment of a disease or condition. Its purpose is to aid daily living activities rather than to cure, mitigate, treat, or prevent a disease.

Diagnostic

No
The device, a power wheelchair, is intended to provide mobility, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "battery powered, motorized mobility vehicle" and a "power wheelchair," indicating it is a physical hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Description and Intended Use: The description clearly states that the Discovery power wheelchair is a "battery powered, motorized mobility vehicle" intended to "provide mobility to persons limited to a sitting position." This is a device for physical mobility, not for analyzing biological samples.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples
  • Detecting biomarkers or analytes
  • Providing diagnostic information about a patient's health status

The information provided describes a medical device used for mobility assistance, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.

Product codes (comma separated list FDA assigned to the subject device)

ITI

Device Description

The Discovery power wheelchair is a battery powered, motorized mobility vehicle. The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.

The Discovery is designed to be durable, dependable, sporty and aesthetically appealing while being economically priced.

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)

As required by FDA's July 26, 1995 draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Application for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles", the Discovery Power Wheelchair was tested in accordance with ISO/CD 7176-21 and the ANSI/RESNA Vol.2 Section 21 Amendments for powered wheelchairs and motorized scooters. In all instances, the Discovery Power Wheelchair met the required performance criteria and functioned as intended.

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.

K852811

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

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).

Summary

0

K014127

MAR 1 5 2002

510(k) Summary

Innovation In Motion's 510(k) Premarket Notification Karma Discovery Series Power Wheelchair

Submitter's Name, Address, Telephone, Fax Number, Contact Name

Karma Medical Products, Co., LTD. No. 29 Cheng-Kung First Street Min-Hsiung Industrial Zone Chia-Yi Hsien, 621. Taiwan Phone: [phone] Fax: [phone]

Manufacturer's Name, Address, Telephone, and Fax Numbers

Karma Medical Products, Co., LTD. No. 29 Cheng-Kung First Street Min-Hsiung Industrial Zone Chia-Yi Hsien, 621. Taiwan Phone: [phone] Fax: [phone]

Name of Device

Karma Discovery Series Power Wheelchair

Name of Applicant/Submission Correspondent, Address, Phone, Fax Numbers, and Contact Name:

Innovation In Motion 900 Growth Parkway PO Box 507 Angola, IN 46703 Phone [phone] Fax: [phone] Rick Michael - [e-mail]

Date Prepared

December 2001

Common or Usual Name Power Wheelchair

C I

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Classification Name Wheelchair, Power

Predicate Devices

The product that is substantially equivalent to the Discovery is Invacare's Ranger X rear wheel drive power wheelchair (K852811).

Intended Use

The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.

Technological Characteristics and Substantial Equivalence

Device Description:

The Discovery power wheelchair is a battery powered, motorized mobility vehicle. The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.

The Discovery is designed to be durable, dependable, sporty and aesthetically appealing while being economically priced.

Substantial Equivalence:

The product that is substantially equivalent to the Discovery rear wheel power wheelchair is Invacare's Ranger X power wheelchair (K852811).

Both of these products are battery powered wheelchairs with the same intended function and use-- the provision of mobility to persons limited to a sitting position that have the canability of operating a powered wheelchair. Similarities include large wheels with attached motor/gearbox drive mechanisms, smaller pivoting casters for turning, and joystick operated motor controllers to engage system motion and steer the wheelchair. They are all constructed from the same basic materials, have the same basic operational principles, and all use DC batteries as their source of power.

Performance Data:

As required by FDA's July 26, 1995 draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Application for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles", the Discovery Power Wheelchair was tested in accordance with ISO/CD 7176-21 and the ANSI/RESNA Vol.2 Section 21 Amendments for powered wheelchairs and motorized scooters. In all instances, the Discovery Power Wheelchair met the required performance criteria and functioned as intended.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2002

Mr. Rick Michael North American Sales Manager Vestil Manufacturing Corporation 900 Growth Parkway Angola, Indiana 46703

Re: K014127

Trade/Device Name: Karma Discovery Series Power Wheelchair Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: December 14, 2001 Received: December 17, 2001

Dear Mr. Michael:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Rick Michael

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerery, yours,

Mark N Mather

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Applicant: Innovation In Motion

Karma Medical Products Submitter:

Name of Device: Karma Discovery Series Power Wheelchair age___________________________________________________________________________________________________________________

510(k) Number (if known):_KOL412 7

Device Name: Power Wheelchair

Indications For Use:

The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number	K014127

Prescription Use OR Over-The-Counter Use

Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96