Cleared Traditional

K230701 - Stim2Go

K230701 is an FDA 510(k) clearance for Stim2Go, manufactured by PAJUNK GmbH Medizintechnologie. The device is a Class 2 Physical Medicine device with 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)
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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

FDA 510(k) Submission Details - K230701

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.

IPF Device Classification - Class 2, Special Controls

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.

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All 257
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