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Power Chair Model HS-5600

by Warepalmy Enterprise, LLC (Usa)

510(k) K002983

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002983 Date11 Oct 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
C.T.M. Power Chair, Model Hs-5600
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, 1 Oct 2026

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

This is a Powered Wheelchair, a motorized mobility device designed to assist individuals with limited mobility in indoor and outdoor environments. The chair provides electric propulsion for independent movement, featuring adjustable controls and seating to accommodate varying user needs and postures. It is classified as a Class II medical device under FDA regulations, intended for long-term use by individuals requiring powered mobility assistance.

The Power Chair Model HS-5600 is supplied as a reusable device, intended for clinical or home use under professional supervision or user training. It is not sterile and requires regular maintenance, including battery charging and mechanical inspections. The chair has a maximum load capacity of 400 lbs and is designed for both indoor and outdoor use, though outdoor performance may depend on terrain and weather conditions. It has received FDA 510(k) clearance under the Physical Medicine advisory committee, with a decision classification of Substantially Equivalent (SESE). No MRI safety information is specified.

Other devices from Warepalmy Enterprise, LLC (Usa)

Questions

AI-generated answers, 1 Oct 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 HS-5600 Powered Wheelchair designed for?

    The HS-5600 Powered Wheelchair is designed to assist individuals with limited mobility by providing electric propulsion for independent movement. It is intended for long-term use in both indoor and outdoor environments, with adjustable controls and seating to accommodate varying user needs and postures. This makes it suitable for clinical or home settings under professional supervision or user training.

  • Is the HS-5600 Powered Wheelchair reusable or single-use?

    The HS-5600 Powered Wheelchair is a reusable device. It is not intended for single-use and requires regular maintenance, including battery charging and mechanical inspections, to ensure safe and reliable operation over time.

  • What is the maximum weight capacity of the HS-5600 Powered Wheelchair?

    The HS-5600 Powered Wheelchair has a maximum load capacity of 400 lbs. This capacity ensures it can accommodate a wide range of users while maintaining stability and safety during use.

  • Does the HS-5600 Powered Wheelchair come sterile?

    No, the HS-5600 Powered Wheelchair is not supplied sterile. It is intended for reusable clinical or home use, and sterility is not applicable or required for this type of device.

  • What maintenance does the HS-5600 Powered Wheelchair require?

    The HS-5600 Powered Wheelchair requires regular maintenance, including battery charging to ensure proper function and mechanical inspections to verify structural integrity and operational safety. Routine checks help extend the device’s lifespan and ensure reliable performance for users.