Cleared Traditional

K150139 - Rachel's Remedy (FDA 510(k) Clearance)

Class I Physical Medicine device.

K150139 · Rachel'S Remedies, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.