510(k) K233046

Electrical Neuromuscular Stimulator, Cure Trio by Oriental Inspiration Limited — Product Code GZJ

K233046 is an FDA 510(k) premarket notification submitted by Oriental Inspiration Limited for the device "Electrical Neuromuscular Stimulator, Cure Trio". The FDA issued a decision of Substantially Equivalent on April 19, 2024. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Oriental Inspiration Limited has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2024
Date Received
September 25, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type