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ASH-7000

by U.S. Table, Inc. 510(k)

Active United States

510(k) K951228

Overview

The ASH-7000 is a powered traction equipment device classified under FDA class 2 with product code ITH and regulation number 890.5900. It is designated for use in physical medicine and was determined to be substantially equivalent to a predicate device through a traditional 510(k) clearance process.

The device was manufactured by U.S. Table, Inc., received FDA 510(k) clearance under K951228 on May 17, 1995, following submission on March 20, 1995. It is authorized for distribution in the United States and is associated with multiple facility establishment identifiers and registration numbers as listed in the openFDA data.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK951228 Date17 May 1995ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
ITH
Device Class
Class II
Regulation
21 CFR Part 890.5900
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Other devices from U.S. Table, Inc.