Cleared Traditional

OrthoGold 100

K210451 · Tissue Regeneration Technologies, LLC · Physical Medicine
May 2021
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K210451 is an FDA 510(k) clearance for the OrthoGold 100, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Tissue Regeneration Technologies, LLC (Woodstock, US). The FDA issued a Cleared decision on May 5, 2021, 78 days after receiving the submission on February 16, 2021. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K210451 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2021
Decision Date May 05, 2021
Days to Decision 78 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ISA — Massager, Therapeutic, Electric
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5660