FDA product code OSG: Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch

OSG is the FDA product code for piezo-electric stimulator for relief of mosquito bite itch. It is a Class II device, regulated under 21 CFR 882.5894 and reviewed by the Neurology panel. Devices under OSG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 2 De Novo requests were granted under it.

Definition

Relief / Reduction of Mosquito Bite Itch

Classification

FieldValue
Device namePiezo-Electric Stimulator For Relief Of Mosquito Bite Itch
Device classClass II
Regulation21 CFR 882.5894
Review panelNE — Neurology
Medical specialtyNeurology
Premarket route510(k) exempt

Recalls for OSG devices

openFDA lists no recalls for product code OSG.

Frequently asked questions

What is FDA product code OSG?

OSG is the FDA product code for piezo-electric stimulator for relief of mosquito bite itch. It is a Class II device, regulated under 21 CFR 882.5894 and reviewed by the Neurology panel.

What device class is OSG?

Class II, regulation 21 CFR 882.5894. Typical premarket route: 510(k) exempt.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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