Cleared Traditional

Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)

K220485 · The Anspach Effort, Inc. · Neurology
May 2022
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K220485 is an FDA 510(k) clearance for the Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC), a Motor, Drill, Electric (Class II — Special Controls, product code HBC), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on May 19, 2022, 91 days after receiving the submission on February 17, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4360.

Submission Details

510(k) Number K220485 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 2022
Decision Date May 19, 2022
Days to Decision 91 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBC — Motor, Drill, Electric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4360