Cleared Traditional

Electrical Neuromuscular Stimulator, Cure Trio

K233046 · Oriental Inspiration Limited · Neurology
Apr 2024
Decision
207d
Days
Class 2
Risk

About This 510(k) Submission

K233046 is an FDA 510(k) clearance for the Electrical Neuromuscular Stimulator, Cure Trio, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Oriental Inspiration Limited (Hong Kong, CN). The FDA issued a Cleared decision on April 19, 2024, 207 days after receiving the submission on September 25, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K233046 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2023
Decision Date April 19, 2024
Days to Decision 207 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890

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