Cleared Traditional

HYDROTEC LOW AIR LOSS THERAPY BED

K970363 · Apex Metal, Inc. · Physical Medicine
Nov 1997
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K970363 is an FDA 510(k) clearance for the HYDROTEC LOW AIR LOSS THERAPY BED, a Bed, Flotation Therapy, Powered (Class II — Special Controls, product code IOQ), submitted by Apex Metal, Inc. (Los Angeles, US). The FDA issued a Cleared decision on November 17, 1997, 290 days after receiving the submission on January 31, 1997. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5170.

Submission Details

510(k) Number K970363 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 1997
Decision Date November 17, 1997
Days to Decision 290 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IOQ — Bed, Flotation Therapy, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5170

Similar Devices — IOQ Bed, Flotation Therapy, Powered

All 56
Hill-Rom Wireless Connectivity Module
K143414 · Hill-Rom · Mar 2015
TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2
K122473 · Hill-Rom · Jun 2013
NURSE'S AID PATIENT ROTATION SYSTEM
K973624 · Air Med Assist Products · Jan 1998
AIRTEC2 LOW AIR LOSS THERAPY BED
K970364 · Apex Metal, Inc. · Nov 1997
TOTALCARE., MODULAR THERAPY SYSTEM (MTS)
K970636 · Hill-Rom, Inc. · Aug 1997
SILKAIR LOW AIRLOSS THERAPY
K964873 · Hill-Rom, Inc. · Jul 1997