Cleared Traditional

STANDEX

K885343 · Alt, Inc. · Physical Medicine
May 1989
Decision
124d
Days
Class 1
Risk

About This 510(k) Submission

K885343 is an FDA 510(k) clearance for the STANDEX, a Exerciser, Non-measuring (Class I — General Controls, product code ION), submitted by Alt, Inc. (Redwood Falls, US). The FDA issued a Cleared decision on May 1, 1989, 124 days after receiving the submission on December 28, 1988. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number K885343 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1988
Decision Date May 01, 1989
Days to Decision 124 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ION — Exerciser, Non-measuring
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5370