Cleared Traditional

K832464 - MASSAGE TABLE AAT-100 (FDA 510(k) Clearance)

Aug 1983
Decision
21d
Days
Class 2
Risk

K832464 is an FDA 510(k) clearance for the MASSAGE TABLE AAT-100. This device is classified as a Table, Physical Therapy, Multi Function (Class II - Special Controls, product code JFB).

Submitted by R&D Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983, 21 days after receiving the submission on July 26, 1983.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5880.

Submission Details

510(k) Number K832464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1983
Decision Date August 16, 1983
Days to Decision 21 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code JFB — Table, Physical Therapy, Multi Function
Device Class Class II - Special Controls
CFR Regulation 21 CFR 890.5880