(64 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Taiwan King Strong Powered Wheelchair TP01 is an indoor / outdoor electric wheelchair that is battery operated. It has a base with four-wheeled with a seat and armrests. The movement of the powered wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
This is a 510(k) premarket notification for a powered wheelchair, not a medical device driven by an algorithm. Therefore, the requested information about acceptance criteria, study details, and AI performance metrics is not applicable in this context.
The document discusses performance testing in a general sense, focusing on electrical and mechanical safety standards for a physical device, not an algorithm.
Here's a breakdown of what the document does provide:
- Device Name: Taiwan King Strong Powered Wheelchair TP01
- Intended Use: To provide mobility to persons restricted to a seated position.
- Performance Testing Mentioned:
- EMC Report
- ANSI / RESNA WC/Vol.2-1998 (relevant to electrically powered wheelchairs)
- CISPR 11: 1990
- EN61000-3-2: 1995
- IEC61000-3-3: 1995
- Substantial Equivalence Comparison: COMFORT Powered Wheelchair, Traveller LY-EB103 (K030356)
- Key finding: The electronic systems are the same and passed UL certification, assuring the same safety level. Differences are in controller, agility, ease of storage/transportation, overall dimension, tire size, and weight, but these do not affect safety.
In summary, as this is a physical product (a wheelchair) and not a software-driven device or diagnostic tool, the questions regarding acceptance criteria for algorithms, ground truth, expert adjudication, AI performance, multi-reader studies, and training/test set data provenance are not relevant. The "study" mentioned is the battery of compliance tests against established safety and performance standards for wheelchairs.
§ 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).