Cleared Traditional

PRO-SHIATSU PORTABLE MASSAGER (K940621) - FDA 510(k) Clearance

Class I Physical Medicine device.

K940621 · Westminster International Co., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
128d
Days
Class 1
Risk

K940621 is an FDA 510(k) clearance for the PRO-SHIATSU PORTABLE MASSAGER. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Westminster International Co., Inc. (Atlanta, US). The FDA issued a Cleared decision on June 22, 1994 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Westminster International Co., Inc. devices

Submission Details

510(k) Number K940621 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 14, 1994
Decision Date June 22, 1994
Days to Decision 128 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 115d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ISA Massager, Therapeutic, Electric

All 99
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K940621.
VMAT PRO
K243488 · Termosalud · Feb 2025
ShockPhysio Mobile (model SW3200 Basic)
K240358 · Shenzhen Dongdixin Technology Co., Ltd. · Jun 2024
BTL-094
K221865 · BTL Industries, Inc. · Apr 2023
Omnispec ED1000
K210166 · Medispec, Ltd. · Jan 2023
OW100S (model OW100S-US)
K213120 · Tissue Regeneration Technologies, LLC Dba AS Softwave Trt · Oct 2022
DolorClast Radial
K220538 · E.M.S Electro Medical Systems S.A · Jul 2022