Cleared Traditional

SENSORY ROLLER MASSAGER

K833090 · Maddak, Inc. · Physical Medicine
Oct 1983
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K833090 is an FDA 510(k) clearance for the SENSORY ROLLER MASSAGER, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983, 32 days after receiving the submission on September 12, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K833090 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1983
Decision Date October 14, 1983
Days to Decision 32 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ISA — Massager, Therapeutic, Electric
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5660