Cleared Traditional

K150139 - Rachel's Remedy

K150139 is an FDA 510(k) clearance for Rachel's Remedy, manufactured by Rachel'S Remedies, LLC. The device is a Class 1 Physical Medicine device with product code IMA cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K150139 · Rachel'S Remedies, LLC · Physical Medicine device
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May 2015
Decision
120d
Days
Class 1
Risk

K150139 is an FDA 510(k) clearance for the Rachel's Remedy. Classified as Pack, Heat, Moist (product code IMA), Class I - General Controls.

Submitted by Rachel'S Remedies, LLC (Buffalo, US). The FDA issued a Cleared decision on May 22, 2015 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5730 - 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 Rachel'S Remedies, LLC devices

FDA 510(k) Submission Details - K150139

510(k) Number K150139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2015
Decision Date May 22, 2015
Days to Decision 120 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 115d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

IMA Device Classification - Class 1, General Controls

Product Code IMA Pack, Heat, Moist
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5730
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.