Cleared Traditional

K873819 - MODIFIED STRESS MACHINE

K873819 is the FDA 510(k) clearance for MODIFIED STRESS MACHINE by S.J.F., Inc.. It is a Class 1 Physical Medicine device (product code ISA) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K873819 · S.J.F., Inc. · Physical Medicine device
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Jan 1988
Decision
123d
Days
Class 1
Risk

K873819 is an FDA 510(k) clearance for the MODIFIED STRESS MACHINE. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by S.J.F., Inc. (Mars, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 123 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 S.J.F., Inc. devices

Submission Details

510(k) Number K873819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1987
Decision Date January 22, 1988
Days to Decision 123 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
8d slower than avg
Panel avg: 115d · This submission: 123d
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 15
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K873819.
OMRON MASSAGER MODEL HM-45
K935459 · Omron Healthcare, Inc. · Mar 1994
OMBRON TWIN-HEAD MASSAGER MODEL HM-101
K935462 · Omron Healthcare, Inc. · Mar 1994
OMRON MASSAGER MODEL HM-102
K935581 · Omron Healthcare, Inc. · Mar 1994
SENSORY ROLLER MASSAGER
K833090 · Maddak, Inc. · Oct 1983
MAGIC CUSHION MASSAGER
K810447 · Fred Sammons, Inc. · Mar 1981