Cleared Traditional

Biofeedback Nerve and Muscle Stimulator (K202648) - FDA 510(k) Clearance

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

K202648 · Shenzhen Konmed Technology Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
88d
Days
Class 2
Risk

K202648 is an FDA 510(k) clearance for the Biofeedback Nerve and Muscle Stimulator. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Shenzhen Konmed Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 8, 2020 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Konmed Technology Co., Ltd. devices

Submission Details

510(k) Number K202648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2020
Decision Date December 08, 2020
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 Consultant

Feiying Drug & Medical Consulting Technical Service Group
Tracy Che

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 73
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K202648.
InMode Evolve System with the Tone Applicator
K201285 · Inmode , Ltd. · Mar 2021
PowerDot PD-01MT2 Muscle Stimulator
K210269 · Smartmissimo Technologies Pte, Ltd. · Feb 2021
emField
K203488 · Zimmer Medizinsysteme GmbH · Feb 2021
Physiq
K202079 · El.En Electronic Engineering Spa · Nov 2020
Avid CT2
K202490 · Vision Quest Industries Inc./Dba VQ Orthocare · Nov 2020
g.Estim FES
K200088 · G.Tec Medical Engineering GmbH · Oct 2020