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Medical Treatment Chair T400, T500, T600

by Fresenius Medical Care South Asia Pacific Pty, Ltd.

510(k) K091727

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 NumberK091727 Date6 Jul 2009ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
INO
FDA applicant
Fresenius Medical Care South Asia Pacific Pty , Ltd.
Device Class
Class II
Regulation
21 CFR Part 890.3110
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Medical Treatment Chair, models T400, T500, and T600, is an electric positioning chair. It is designed to provide stable and adjustable support for patients during various clinical procedures.

This device is authorized under FDA 510(k) clearance K091727. It is classified as an electric positioning chair under regulation number 890.3110.

Other devices from Fresenius Medical Care South Asia Pacific Pty, Ltd.

Questions

AI-generated answers, 27 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 primary purpose of the Medical Treatment Chair?

    The T400, T500, and T600 models are electric positioning chairs designed to provide stable and adjustable support for patients undergoing various clinical procedures.

  • What regulatory authorization does this device hold?

    This device is authorized under FDA 510(k) clearance K091727 and is classified as an electric positioning chair under regulation number 890.3110.

  • Which models are included in this product line?

    The product line consists of three specific models: the T400, T500, and T600, all of which are designed for electric patient positioning.