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SIMS CHAIR

by Twin City Surgical, Inc. 510(k)

Active United States

510(k) K861632

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK861632 Date27 May 1986ClearedStatusActive

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  • Withdrawn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
IKK
Device Class
Class II
Regulation
21 CFR Part 890.1925
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 SIMS CHAIR is a system for isokinetic testing and evaluation, classified under device class 2 with product code IKK. It is designed for use in physical medicine applications as indicated by the advisory committee classification.

The device received traditional 510(k) clearance (K861632) from the FDA on May 27, 1986, and is substantially equivalent to a predicate device. It is manufactured by Twin City Surgical, Inc. and is regulated under 21 CFR 890.1925.

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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 SIMS CHAIR used for?

    The SIMS CHAIR is designed for isokinetic testing and evaluation in physical medicine applications, as indicated by its advisory committee classification under product code IKK.

  • Who manufactures the SIMS CHAIR and where is it located?

    The SIMS CHAIR is manufactured by Twin City Surgical, Inc., located at 2800 N. Fairview Ave., St. Paul, MN 55113, United States.

  • What regulatory pathway was used for the SIMS CHAIR and when was it cleared?

    The SIMS CHAIR received traditional 510(k) clearance from the FDA on May 27, 1986, under K861632, and is substantially equivalent to a predicate device.

  • What device class and regulation number apply to the SIMS CHAIR?

    The SIMS CHAIR is classified as a Class 2 medical device and is regulated under 21 CFR 890.1925, with product code IKK for isokinetic testing and evaluation systems.