Cleared Traditional

Stim2Go

K230701 · PAJUNK GmbH Medizintechnologie · Physical Medicine
Nov 2023
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K230701 is an FDA 510(k) clearance for the Stim2Go, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on November 24, 2023, 255 days after receiving the submission on March 14, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K230701 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2023
Decision Date November 24, 2023
Days to Decision 255 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850