Relay Power Wheelchair
by Dalton Instrument Corp. 510(k)
Active
510(k) K101611
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101611 | Date29 Sep 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
Overview
AI-generated summary, 24 Sep 2026
The Relay Power Wheelchair is a Class 2 medical device designed for mobility assistance. It is a powered wheelchair that falls under the product code ITI and is categorized under Physical Medicine.
This device is manufactured by Dalton Instrument Corp. and received FDA 510(k) clearance on September 29, 2010, with a decision of Substantially Equivalent. The Relay Power Wheelchair is regulated under number 890.3860 and is intended for use as a mobility aid.
Other devices from Dalton Instrument Corp.
Questions
AI-generated answers, 24 Sep 2026
What is the Relay Power Wheelchair used for?
The Relay Power Wheelchair is designed for mobility assistance as a powered wheelchair. It is intended to help individuals with mobility impairments move independently and is categorized under Physical Medicine.
How is the Relay Power Wheelchair supplied?
The Relay Power Wheelchair is manufactured by Dalton Instrument Corp. and is supplied as a complete mobility aid device. It is not specified in the data whether it comes in different models or sizes.
What is the regulatory status of the Relay Power Wheelchair?
The Relay Power Wheelchair received FDA 510(k) clearance on September 29, 2010, with a decision of Substantially Equivalent. It is regulated under number 890.3860 and is classified as a Class 2 medical device.
Is the Relay Power Wheelchair single-use or reusable?
The device data does not specify whether the Relay Power Wheelchair is designed for single-use or multiple uses. As a powered wheelchair, it is typically designed for long-term use rather than disposable single-use applications.