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System 90 And 95

by Folio Products, Inc. 510(k)

Active United States

510(k) K905293

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK905293 Date6 Dec 1990ClearedStatusActive

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  • Withdrawn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, 26 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 System 90 And 95 is a powered wheelchair, classified as a device in the Physical Medicine specialty. It is substantially equivalent to other devices on the market.

The System 90 And 95 is supplied by Folio Products, Inc. and has been cleared by the FDA with the K number K905293. The device is classified under the product code ITI and regulation number 890.3860. It is intended for use in the Physical Medicine field.

Other devices from Folio Products, Inc.

  • System 70 and 100

    Class II

  • System 50

    Class II

Questions

AI-generated answers, 26 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 System 90 And 95 used for?

    The System 90 And 95 is used in the Physical Medicine field, intended to provide mobility assistance.

  • Is the System 90 And 95 cleared by the FDA?

    Yes, the System 90 And 95 has been cleared by the FDA with the K number K905293, indicating it is substantially equivalent to other devices on the market.

  • What is the product code for the System 90 And 95?

    The product code for the System 90 And 95 is ITI, under the regulation number 890.3860.