Cleared Traditional

K223620 - Reprieve by RegenesisTM
(FDA 510(k) Clearance)

K223620 · Regenesis Biomedical, Inc. · Physical Medicine
May 2023
Decision
170d
Days
Class 2
Risk

K223620 is an FDA 510(k) clearance for the Reprieve by RegenesisTM, a Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMJ), submitted by Regenesis Biomedical, Inc. (Scottsdale, US). The FDA issued a Cleared decision on May 24, 2023, 170 days after receiving the submission on December 5, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5290.

Submission Details

510(k) Number K223620 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2022
Decision Date May 24, 2023
Days to Decision 170 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IMJ — Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5290