A-BEC 46 Powered Wheelchair
by A-Bec Mobility, Inc. 510(k)
Active
510(k) K865003
Overview
The A-BEC 46 is a powered wheelchair, a motorised mobility device designed to assist individuals with limited mobility in independent movement. It is classified as a Class II medical device under FDA regulations, intended for use in physical medicine settings to enhance mobility for users who require electric propulsion.
This device is supplied as a reusable mobility aid, intended for clinical or home use under professional supervision or user training. It is not sterile and requires regular maintenance, including battery checks and mechanical inspections. The A-BEC 46 has received FDA 510(k) clearance (K865003) under the Traditional 510(k) review pathway, with a decision date of February 6, 1987, and is regulated under the product code ITI. No MRI safety or single-use specifications are indicated.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK865003 | Date6 Feb 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- A-Bec 46
- 510(k) Number
- FDA Product Code
- ITI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from A-Bec Mobility, Inc.
Questions
What is the A-BEC 46 used for?
The A-BEC 46 is a powered wheelchair designed to assist individuals with limited mobility in achieving independent movement. It is intended for use in physical medicine settings, such as clinics or homes, to provide electric propulsion for users who require mobility assistance. This device is not sterile and is meant for reusable clinical or home use under professional supervision or user training.
Is the A-BEC 46 a single-use or reusable device?
The A-BEC 46 is a reusable mobility aid. It is not intended for single-use and requires regular maintenance, including battery checks and mechanical inspections, to ensure safe and effective operation. Reusability is a key feature for clinical or home use under professional oversight.
Does the A-BEC 46 come sterile?
No, the A-BEC 46 is not supplied sterile. Since it is a reusable device intended for clinical or home use, sterility is not applicable. Proper cleaning and maintenance protocols must be followed to ensure hygiene and functionality.
What regulatory pathway was used for the A-BEC 46?
The A-BEC 46 received FDA 510(k) clearance under the Traditional 510(k) review pathway, with a decision date of February 6, 1987. It is classified as a Class II medical device and regulated under the product code ITI. The device was reviewed by the Physical Medicine Advisory Committee.
How should the A-BEC 46 be stored?
While specific storage instructions are not detailed in the provided data, reusable powered wheelchairs like the A-BEC 46 generally require storage in a clean, dry environment to prevent damage to mechanical components and batteries. Users should follow manufacturer guidelines for proper storage to maintain functionality and longevity, particularly ensuring the device is fully charged and protected from extreme temperatures.