(8 days)
Not Found
No
The document describes a standard powered wheelchair and explicitly states that mentions of AI, DNN, or ML were "Not Found".
No
The device is described as a transportation vehicle for mobility, not as a device used for treating or alleviating a disease or condition. Its purpose is to provide mobility, which is assistive rather than therapeutic.
No
The device description and intended use clearly state that the HAIDA HD21 powered wheelchair is a transportation device for mobility, not a device used to diagnose medical conditions.
No
The device description explicitly states it is a "powered wheelchair," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing transportation for disabled or elderly persons. This is a mobility aid, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the mechanical and electrical aspects of a powered wheelchair. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document explicitly states "Not Found" for key elements typically associated with IVDs, such as:
- Image processing
- AI/ML
- Input imaging modality
- Anatomical site (in the context of diagnostic testing)
- Performance studies (which would involve metrics like sensitivity, specificity, etc., relevant to diagnostic accuracy)
In summary, the HAIDA HD21 powered wheelchair is a medical device, but it falls under the category of a mobility aid, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HAIDA HD21 powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.
It is a motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The HAIDA HD21 powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market.
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.
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
§ 890.3860 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).
0
KOr2288
Image /page/0/Picture/1 description: The image shows a logo with a globe-like design. Inside the globe, there are the letters "HD" in a bold, sans-serif font. Below the globe, there are two Chinese characters. The logo appears to be for a company or organization with international connections.
Jiangyin East China Medical Technology Co., Ltd.
No.555, Qinfeng Road, Huashi Town, Jiangyin City, Jiangsu, China, 214421 TEL: +86-510-86218310 FAX: +86-510-86218308
510(k) Summary
AUG 1 9 2008
Device
Trade name: HAIDA HD21 powered wheelchair Common name: Powered wheelchair Classification name: Powered wheelchair Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3860 Product Code: ITI Classification: Class II
Predicate devices
CWD01 (K062888) / EMG Technology Co. Ltd. KV10HB(K072027) / KWANG YANG MOTOR CO., LTD.
Intend use of device
HAIDA HD21 powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
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