Cleared Traditional

ers2 - ergoline Rehabilitation System

K212883 · Ergoline GmbH · Cardiovascular

Jul 2022

Decision

308d

Days

Class 2

Risk

About This 510(k) Submission

K212883 is an FDA 510(k) clearance for the ers2 - ergoline Rehabilitation System, a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Ergoline GmbH (Bitz, DE). The FDA issued a Cleared decision on July 15, 2022, 308 days after receiving the submission on September 10, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K212883 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2021
Decision Date	July 15, 2022
Days to Decision	308 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2910