Cleared Traditional

Rachel's Remedy

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

About This 510(k) Submission

K150139 is an FDA 510(k) clearance for the Rachel's Remedy, a Pack, Heat, Moist (Class I — General Controls, product code IMA), submitted by Rachel'S Remedies, LLC (Buffalo, US). The FDA issued a Cleared decision on May 22, 2015, 120 days after receiving the submission on January 22, 2015. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5730.

Submission Details

510(k) Number K150139 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code IMA — Pack, Heat, Moist
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5730