(21 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard powered wheelchair and explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device's intended use is to provide mobility, which is assistive rather than therapeutic. Therapeutic devices are typically used for treatment, diagnosis, or prevention of disease.
No
The device is described as a powered wheelchair/scooter intended for mobility, not for diagnosing any medical conditions. The performance studies mentioned are related to electrical and safety standards for wheelchairs.
No
The device description clearly states it is an "indoor / outdoor electric scooter" with physical components like a base, wheels, seat, armrests, and a steering column, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide mobility to persons restricted to a seated position." This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a powered wheelchair/scooter, which is a mobility aid. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids/samples.
- Detecting or measuring specific substances (analytes) in samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The device is clearly a medical device intended for mobility assistance, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The WU'S Powered Wheelchair MAMBO 36X is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armirests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembly d for transport and is provided with an onboard battery charger.
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)
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and th chargers - requirements and test methods)
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
JUL - 6 2006
NO. 225, YUAN-PIER ST., HSIN C TEL: 886-3-5382105 FAX . 886-3-5387 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net