Cleared Traditional

K232786 - Stimulation System (PA series

K232786 is the FDA 510(k) clearance for Stimulation System (PA series by Edan Instruments, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 248-day FDA review.

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.

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 K232786.
eMVFit (MVF-10M)
K240992 · Weero Co., Ltd. · Oct 2024
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K240234 · BTL Industries, Inc. · Aug 2024
MYOTouch Muscle Stimulator
K233098 · Sunmed, LLC · Aug 2024
accufit
K233926 · Mettler Electronics Corporation · Mar 2024
M-Wave
K233485 · Zynex Medical, Inc. · Jan 2024
BTL-899M
K232937 · BTL Industries, Inc. · Dec 2023