Cleared Traditional

K202031 - Talent-Pro Electromagnetic Stimulator

K202031 is an FDA 510(k) clearance for Talent-Pro Electromagnetic Stimulator, manufactured by Remed Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K202031 · Remed Co., Ltd. · Physical Medicine device
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May 2021
Decision
288d
Days
Class 2
Risk

K202031 is an FDA 510(k) clearance for the Talent-Pro Electromagnetic Stimulator. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Remed Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on May 6, 2021 after a review of 288 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 Remed Co., Ltd. devices

FDA 510(k) Submission Details - K202031

510(k) Number K202031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2020
Decision Date May 06, 2021
Days to Decision 288 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
173d slower than avg
Panel avg: 115d · This submission: 288d
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.

Regulatory Consultant

K-Biotech
Kyungyoon Kang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 165
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K202031.
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