Cleared Traditional

RELAXU-1

K950411 · Kinsei Shiatsu, Inc. · Physical Medicine
Aug 1995
Decision
183d
Days
Class 1
Risk

About This 510(k) Submission

K950411 is an FDA 510(k) clearance for the RELAXU-1, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Kinsei Shiatsu, Inc. (Torrance, US). The FDA issued a Cleared decision on August 2, 1995, 183 days after receiving the submission on January 31, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K950411 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 1995
Decision Date August 02, 1995
Days to Decision 183 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

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