Cleared Traditional

Stimulation System (PA series, PR series, S series and Q series)

K232786 · Edan Instruments, Inc. · Physical Medicine
May 2024
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K232786 is an FDA 510(k) clearance for the Stimulation System (PA series, PR series, S series and Q series), a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on May 16, 2024, 248 days after receiving the submission on September 11, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K232786 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850

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