Cleared Traditional

K232786 - Stimulation System (PA series, PR series, S series and Q series) (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232786 · Edan Instruments, Inc. · Physical Medicine device

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May 2024

Decision

248d

Days

Class 2

Risk

K232786 is an FDA 510(k) clearance for the Stimulation System (PA series, PR series, S series and Q series). Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on May 16, 2024 after a review of 248 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 Edan Instruments, Inc. devices

Submission Details

510(k) Number	K232786 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 11, 2023
Decision Date	May 16, 2024
Days to Decision	248 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

133d slower than avg

Panel avg: 115d · This submission: 248d

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.