The Danyang Huayi K7 wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid. mechanical, steel frame and nylon upholstery back and seat that meet ISO 7176-16: Resistance to ignition of Upholstered parts. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Danyang Huavi K7 wheelchair is intended for the use in indoors and outdoors, over smooth surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that free of large obstacles and inclines greater than 9 degrees.

AI/ML Overview

The Danyang Huayi K7 Wheelchair is a mechanical wheelchair, and its acceptance criteria and performance are primarily based on conformance to international standards, rather than a clinical study measuring diagnostic performance of an AI-powered device.

Here's a breakdown of the requested information based on the provided document, adapted for a medical device that is not an AI diagnostic tool:

Acceptance Criteria and Device Performance (Danyang Huayi K7 Wheelchair)

The acceptance criteria for the Danyang Huayi K7 Wheelchair are defined by its successful conformance to a series of ISO standards for wheelchairs. The "reported device performance" in this context is the statement of conformity to these standards.

Acceptance Criteria (ISO Standard)	Reported Device Performance
ISO 7176-1: Determination of static stability	Conforms
ISO 7176-3: Determination of efficiency of brakes	Conforms
ISO 7176-5: Determination of overall dimension, mass, and turning space	Conforms
ISO 7176-7: Measurement of seating and wheel dimensions	Conforms
ISO 7176-8: Requirements and test methods for static, impact, and fatigue strengths	Conforms
ISO 7176-11: Test dummies	Conforms
ISO 7176-13: Determination of friction of test surface	Conforms
ISO 7176-15: Requirements for information disclosure, documentation, and labeling	Conforms
ISO 7176-16: Resistance to ignition of upholstered parts - requirements and test methods	Conforms

Additional Information (Not Applicable for a Non-AI Mechanical Device):

The following sections are designed to evaluate AI-powered diagnostic devices. Since the Danyang Huayi K7 Wheelchair is a mechanical mobility device, these criteria are not applicable and are addressed as such below.

Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI diagnostic tool using a test set of data. Testing would involve physical prototypes/production units.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical wheelchair is objective measurements and performance against engineering standards, not expert interpretation of data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device is based on the objective measurements and performance criteria defined by the specified ISO standards for wheelchairs.
The sample size for the training set: Not applicable. This is a mechanical device, not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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K080207

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Danyang Huayi Medical Equipment & Supply Co., LTD One Zhenxing Road, Yunyang Economical Development Zone, Jiangsu Province, 212300 CHINA Telc: 86511-86900809; Fax: 86511-86900805

SUMMARY OF SAFETY AND EFFECTIVENESS

ADMINISTRATION INFORMATION

SPONSOR IDENTIFICATION

MAR 12 2008

Danyang Huayi Medical Supply and Equipment Co., LTD No. 1 Zhenxing Road, Yunyang Economical Development Zone, Danyang City, Jiangsu Province, 212300, CHINA Contact Person: Mr. Tomy Tang Tel: (86511)6900809 Fax:(86511)6900805 email: tomy8034@gmail.com

ESTABLISHMENT REGISTRATION NUMBER: 3006534178

OFFICIAL CONTACT PERSON

Norman F. Estrin, Ph.D. President ESTRIN CONSULTING GROUP, INC. 9109 Copenhaver Drive Potomac, MD 20854 Tel: (301)279-2899 Fax (301)294-0126 estrin@yourFDAconsultant.com

DATE OF PREPARATION OF THIS SUMMARY: January 19, 2008

PROPRIETARY (TRADE) NAME: Danyang HUAYI K7 Wheelchair

COMMON NAME: Wheelchair

CLASSIFICATION NAME: Wheelchair, Mechanical

REGULATION NUMBER: 21 CFR 890.3850

PROPOSED REGULATORY CLASS: Class I

MEDICAL SPECIFICATIONS: Physical Medicine

DEVICE PRODUCT CODES: 89 IOR

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DESCRIPTION OF DEVICE:

INDICATION FOR USE

The Danyang Huayi K7 wheelchair is indicated for providing mobility to persons limited to a sitting position.

CONFORMANCE TO STANDARDS

The Danyang Huayi K7 wheelchair production meets the following standards:

ISO 7176-1 Wheelchair: Determination of static stability ●
. ISO 7176-3 Wheelchair: Determination of efficiency of brakes.
ISO 7176-5: Determination of overall dimension, mass and turning 0 space.
ISO 7176-7: Measurement of seating and wheel dimensions. .
ISO 7176-8 Wheelchair: Requirements and test methods for static, * impact and fatigue strengths.
. ISO 7176-11 Wheelchair: Test dummies
. ISO 7176-13: Determination of friction of test surface.
ISO 7171-15 Wheelchair: Requirements for information disclosure, D documentation and labeling.
ISO 7171-16 Wheelchair: Resistance to ignition of upholstered . parts - requirements and test methods.

PREDICATE DEVICE: Invacare Tracer IV Manual Wheelchair (K935398)

SUBSTANTIAL EQUIVALENCE: The Danyang Huayi K7 wheelchair and Invacare Tracer IV Manual Wheelchair (K935398) are substantially equivalent products in all areas impacting safety and effectiveness.

CONCLUSION: The Danyang K7 wheelchair raises no safety/efficiency issues or makes any claims that differ from the predicate device cited.

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle.

'APR - 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Danyang Huayi Medical Supply & Equipment % Estrin Consulting Group, Inc. Dr. Norman F. Estrin 9109 Copenhaver Drive Potomac. MD 20854

K080207 Re:

Trade/Device Name: Danyang Huayi® K2 and K7 Wheelchairs Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: January 20, 2008 Received: February 5, 2008

Dear Dr. Estrin:

This letter corrects the substantially equivalent letter dated March 12, 2008.

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. Drue, 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. Iisting 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 - Dr. Norman F. Estrin

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Milham

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K080207

Device Trade/Proprietary Name: Danyang Huayi® K7 Wheelchair Indications for Use:

The Danyang Huayi® K7 Wheelchair is indicated for providing mobility to persons limited to a sitting position.

)ver-The-Counter Use Prescription Use X ND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R. Oehl for mx

(Division Sign-Off Division of General, Restorative, and Neurological Devices

Page 1_ of 1

510(k) Number K080207 000012

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Indications for Use

510(k) Number (if known): K080207

Device Trade/Proprietary Name: Danyang Huayi® K2 Wheelchair Indications for Use:

The Danyang Huayi® K2 Wheelchair is indicated for providing mobility to persons limited to a sitting position.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use IND/OR (21 CFR 801 Subpart C)

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

ffice of Device Evaluation (ODE) Concurrence g

tor MKM (Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of

000015

K080207 510(k) Number_________________________________________________________________________________________________________________________________________________________________

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).