Cleared Traditional

RELAXY-THE WONDER HAND

K950322 · Kinsei Shiatsu, Inc. · Physical Medicine
Feb 1995
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K950322 is an FDA 510(k) clearance for the RELAXY-THE WONDER HAND, 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 February 14, 1995, 19 days after receiving the submission on January 26, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K950322 FDA.gov
FDA Decision Cleared SN
Date Received January 26, 1995
Decision Date February 14, 1995
Days to Decision 19 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