Cleared Traditional

K891394 - PM830 ELECTRIC MASSAGER

K891394 is an FDA 510(k) clearance for PM830 ELECTRIC MASSAGER, manufactured by Back IN Action, Inc.. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K891394 · Back IN Action, Inc. · Physical Medicine device
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Apr 1989
Decision
27d
Days
Class 1
Risk

K891394 is an FDA 510(k) clearance for the PM830 ELECTRIC MASSAGER. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Back IN Action, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 10, 1989 after a review of 27 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Back IN Action, Inc. devices

FDA 510(k) Submission Details - K891394

510(k) Number K891394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1989
Decision Date April 10, 1989
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
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 28
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K891394.
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