Cleared Traditional

K230701 - Stim2Go

K230701 is the FDA 510(k) clearance for Stim2Go by PAJUNK GmbH Medizintechnologie. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K230701 · PAJUNK GmbH Medizintechnologie · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
255d
Days
Class 2
Risk

K230701 is an FDA 510(k) clearance for the Stim2Go. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on November 24, 2023 after a review of 255 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all PAJUNK GmbH Medizintechnologie devices

Submission Details

510(k) Number K230701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 115d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 134
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K230701.
accufit
K233926 · Mettler Electronics Corporation · Mar 2024
M-Wave
K233485 · Zynex Medical, Inc. · Jan 2024
BTL-899M
K232937 · BTL Industries, Inc. · Dec 2023
Combo Electrotherapy Device
K231440 · Shenzhen Roundwhale Technology Co. , Ltd. · Nov 2023
NeuroTrigger Basic (NTB)
K223027 · Neurotrigger · Oct 2023
accufit
K223802 · Mettler Electronics Corporation · Oct 2023