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Relay Power Wheelchair

by Dalton Instrument Corp. 510(k)

Active United States

510(k) K101611

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK101611 Date29 Sep 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.