(44 days)
Not Found
No
The description details a standard manual wheelchair with a mechanical frame and wheels, with no mention of AI, ML, or any computational capabilities.
No.
A therapeutic device is typically used for the treatment or prevention of a medical condition. A wheelchair provides mobility support rather than directly treating a condition.
No
Explanation: The Danyang Huayi® K7 Wheelchair is described as a device for providing mobility and does not mention any function related to diagnosing medical conditions.
No
The device description clearly states it is a physical wheelchair with a steel frame, nylon upholstery, wheels, and casters, indicating it is a hardware 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, tissue) to detect diseases, conditions, or infections.
- Device Description: The Danyang Huayi K7 Wheelchair is a mechanical device designed to provide mobility to individuals with limited sitting ability. It does not involve testing biological samples.
- Intended Use: The intended use is for providing mobility, not for diagnostic testing.
The information provided clearly describes a mobility aid, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Danyang Huayi K7 wheelchair is indicated for providing mobility to persons limited to a sitting position.
The Danyang Huayi® K7 Wheelchair is indicated for providing mobility to persons limited to a sitting position.
The Danyang Huayi® K2 Wheelchair is indicated for providing mobility to persons limited to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
89 IOR
IOR
Device Description
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.
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)
Not Found
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.
Invacare Tracer IV Manual Wheelchair (K935398)
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 contains a logo with two curved lines forming a circle in the center. To the right of the logo, there is some text in a foreign language. The text is stacked in two lines, with the top line being slightly larger than the bottom line. The image is black and white and has a simple design.
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
1
Image /page/1/Picture/0 description: The image contains a logo with a stylized symbol on the left and some text on the right. The symbol appears to be two curved shapes enclosing a circle. The text on the right is small and difficult to read, but it seems to be a company name or slogan. The image is simple and likely represents a brand or organization.
DESCRIPTION OF DEVICE:
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.
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.
2
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.
3
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
4
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
5
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_________________________________________________________________________________________________________________________________________________________________