(30 days)
Not Found
No
The device description and intended use clearly describe a basic, mechanical wheelchair with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
A therapeutic device is used to treat a disease, injury, or other medical condition. A basic wheelchair, while providing mobility assistance, does not treat a medical condition but rather aids in overcoming a physical limitation.
No
The device, a wheelchair, provides mobility and does not gather or analyze data for diagnostic purposes. Its function is purely supportive for movement.
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:
- Intended Use: The intended use of the Danyang Huayi® H035 Basic Wheelchair is to provide mobility to individuals who are limited to a sitting position. This is a mechanical function related to physical support and movement, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description details the physical components of a wheelchair (frame, upholstery, wheels, casters). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document explicitly states "Not Found" for mentions of image processing, AI/DNN/ML, input imaging modality, anatomical site, and performance studies with metrics like sensitivity, specificity, etc. These are common elements found in descriptions of IVD devices.
An IVD device is used to perform tests on samples like blood, urine, or tissue to diagnose, monitor, or screen for diseases or other conditions. The Danyang Huayi® H035 Basic Wheelchair does not perform any such tests.
N/A
Intended Use / Indications for Use
The Danyang Huayi® H035 Basic 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
Device Description
The Danyang Huayi H035 Basic Wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel frame and nylon upholstery that meets 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 Huayi H035 wheelchair is intended for use indoors and outdoors, over smooth a surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are 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.
Access Point Medical, AXS-1 Basic Wheelchair (K050280)
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 shows a logo with the word "HUAYI" in bold, black letters at the bottom. Above the text is a stylized graphic consisting of two curved shapes that resemble stylized letter "S" shapes facing each other. In the center of these shapes is a white circle with a black outline, creating a sense of depth and visual interest. The logo appears to be for a company or brand named HUAYI.
丹阳市华一医疗器械有限公司
Danyang Huayi Medical Supply & Equipment Co., Ltd.
SECTION 10.0 SUMMARY OF SAFETY AND EFFECTIVENESS
ADMINISTRATIVE INFORMATON 10.1
SPONSOR IDENTIFICATION 10.11
Danvang Huayi Medical Supply & Equipment, Co. LTD No. 1 Zhenxing Road, Yunyang Economical Development Zone Danyang, Jiangsu, CHINA 212300 Contact Person: Mr. Tomy Tang e-mail: tomy8034@gmail.com Telephone: 011- (86511) 8690-0809 Fax: 011-(86511)8690-0805
FED | 5 2011
10.12 ESTABLISHMENT REGISTRATION NUMBER: Pending
OFFICIAL CONTACT PERSON 10.13
Norman F. Estrin, Ph.D. President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, MD 20854 estrin@yourFDAconsultant.com Tel: (301) 279 -2899 Fax: (301) 294-0126
10.14 DATE OF PREPARATION OF THIS SUMMARY: January 6, 2008
10.15 PROPRIETARY (TRADE) NAME:
Danyang HUAYI H035 Basic Wheelchair
- 10.16 COMMON NAME: Wheelchair
- 10.17 CLASSIFICATION N AME: Wheelchair, Mechanical
- 10.18 REGULATION NUMBERS: 21 CFR 890.3850
- 10.19 PROPOSED REGULATORY CLASS: Class 1
- DEVICE PRODUCT CODES: 89 IOR 10.20
- 10.21 MEDICAL SPECIALTIES: Physical Medicine
DESCRIPTION OF DEVICE 10.3
The Danyang Huayi H035 Basic Wheelchair is a wheelchair that pr
00214
地址:丹阳市云阳经济开发区振兴路1号
1
mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel frame and nylon upholstery that meets 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 Huayi H035 wheelchair is intended for use indoors and outdoors, over smooth a surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 9 degrees.
10.4 INDI CATIONS FOR USE
The Danyang Huayi H035 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position.
10.5 CONFOR MANCE TO STANDARDS
The Danyang Huayi H035 Basic 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 . 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, . documentation and labeling.
ISO 7171-16 Wheelchair: Resistance to ignition of upholstered parts requirements and test methods.
10.6 PREDIC ATE DEVICE
Access Point Medical, AXS-1 Basic Wheelchair (K050280)
10.7 SUBSTANTIAL E QUIVALENCE
The Danyang Huayi H035 Wheelchair and Access Point Medical AXS-1 Basic wheelchair (K080280) are substantially equivalent products in all areas impacting safety and effectiveness.
10.8 CONCLUSION
The Danyang Huayi H035 Basic wheelchair raises no safety/efficiency issues or makes any claims that differ from the predicate device cited.
000215
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
FEB 15 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Danvang Huayi Medical Supply & Equipment, Co., LTD. % Estrin Consulting Group, Inc. Mr. Norman F. Estrin, Ph.D., President 9109 Copenhaver Drive Potomac, MD 20854
Re: K080114
Trade/Device Name: Huayi H035 Basic Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: January 3, 2008 Received: January 17, 2008
Dear Dr. Estrin:
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.
3
Page 2 - Mr. Norman F. Estrin, Ph.D., President
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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millerson
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 4.0
Indications for Use
510(k) Number (if known):
Device Trade/Proprietary Name: Danyang Huayi H035 Basic Wheelchair Indications for Use:
The Danyang Huayi® H035 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position.
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)ver-The-Counter Use Prescription Use X IND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Labels | Values |
|---|---|
| Division Sign-Off | Punh |
| 510(k) Number | L080114 |