Cleared Traditional

K944024 - STIMU-TAP
(FDA 510(k) Clearance)

Dec 1994
Decision
113d
Days
Class 1
Risk

K944024 is an FDA 510(k) clearance for the STIMU-TAP. This device is classified as a Massager, Therapeutic, Electric (Class I - General Controls, product code ISA).

Submitted by Wahl Clipper Corp. (Steriling, US). The FDA issued a Cleared decision on December 8, 1994, 113 days after receiving the submission on August 17, 1994.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K944024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1994
Decision Date December 08, 1994
Days to Decision 113 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