Cleared Traditional

SPIN ROLLERE

K952990 · Kinsei Shiatsu, Inc. · Physical Medicine
Sep 1995
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K952990 is an FDA 510(k) clearance for the SPIN ROLLERE, 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 September 29, 1995, 93 days after receiving the submission on June 28, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K952990 FDA.gov
FDA Decision Cleared SN
Date Received June 28, 1995
Decision Date September 29, 1995
Days to Decision 93 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