Cleared Traditional

K935581 - OMRON MASSAGER MODEL HM-102

K935581 is an FDA 510(k) clearance for OMRON MASSAGER MODEL HM-102, manufactured by Omron Healthcare, Inc.. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K935581 · Omron Healthcare, Inc. · Physical Medicine device
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Mar 1994
Decision
106d
Days
Class 1
Risk

K935581 is an FDA 510(k) clearance for the OMRON MASSAGER MODEL HM-102. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Omron Healthcare, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on March 4, 1994 after a review of 106 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 Omron Healthcare, Inc. devices

FDA 510(k) Submission Details - K935581

510(k) Number K935581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1993
Decision Date March 04, 1994
Days to Decision 106 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

ISA Device Classification - Class 1, General Controls

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 27
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K935581.
BODY RELAXER
K926339 · Conair Corp. · Mar 1994
OMRON MASSAGER MODEL HM-45
K935459 · Omron Healthcare, Inc. · Mar 1994
OMBRON TWIN-HEAD MASSAGER MODEL HM-101
K935462 · Omron Healthcare, Inc. · Mar 1994
INFRADERM
K911727 · Conair Corp. · Feb 1994
BODY SOOTHER
K924518 · Conair Corp. · Oct 1993
BODY TRAINER
K924520 · Conair Corp. · Sep 1993