Cleared Traditional

K894987 - MODEL #520/525 ED/RECOVERY STRETCHER (FDA 510(k) Clearance)

Sep 1989
Decision
28d
Days
Class 1
Risk

K894987 is an FDA 510(k) clearance for the MODEL #520/525 ED/RECOVERY STRETCHER. This device is classified as a Table, Mechanical (Class I - General Controls, product code INW).

Submitted by Medmark, Inc. (Versailles, US). The FDA issued a Cleared decision on September 5, 1989, 28 days after receiving the submission on August 8, 1989.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3750.

Submission Details

510(k) Number K894987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date September 05, 1989
Days to Decision 28 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code INW — Table, Mechanical
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.3750

Similar Devices — INW Table, Mechanical

All 34
JAMES LECKEY PRONE STANDER
K944307 · James Leckey Design · Dec 1994
JAMES LECKEY FREE STANDER
K944308 · James Leckey Design · Dec 1994
EURO TECH MARQUISE CHIROPRACTIC TABLE
K943974 · Progressive Electrical Therapeutics · Sep 1994
EURO TECH PLATINUM CHIROPRACTIC TABLE
K943975 · Progressive Electrical Therapeutics · Sep 1994
TUMBLE FORMS JUNIOR TRISTANDER
K940238 · Camp Intl., Inc. · Mar 1994
ECONOMY HI-LOW MAT TABLE #4110 THRU 4117
K932231 · Bailey Mfg. Co. · Jul 1993