Cleared Traditional

K920526 - STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500
(FDA 510(k) Clearance)

K920526 · Stryker Medical · Physical Medicine
Sep 1992
Decision
230d
Days
Class 1
Risk

K920526 is an FDA 510(k) clearance for the STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500. This device is classified as a Treadmill, Mechanical (Class I — General Controls, product code IOG).

Submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on September 21, 1992, 230 days after receiving the submission on February 4, 1992.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number K920526 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1992
Decision Date September 21, 1992
Days to Decision 230 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IOG — Treadmill, Mechanical
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5370