NFOClass II

Stimulator, Transcutaneous Electrical, Aesthetic Purposes

21 CFR 882.5890 / Neurology

NFO is the FDA product code for Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a class II device type, regulated under 21 CFR 882.5890. As of 2026-09-10, FDA records hold 79 510(k) clearances under this code, the most recent dated 2026-07-23, and 2 recalls.

Classification record

Product code: NFO
Device name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation: 21 CFR 882.5890
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 82
Ingested recalls: 2

Clearances, product code NFO

By decision year

82 clearances under product code NFO with a decision year between 2001 and 2026, 2025 the highest year at 16.

Show the numbers

510(k) clearances under FDA product code NFO by decision year
Year	Clearances
2001	1
2005	1
2007	1
2008	3
2011	3
2012	3
2013	2
2014	2
2015	2
2016	2
2017	7
2018	5
2019	3
2020	2
2021	7
2022	2
2023	8
2024	5
2025	16
2026	7

Applicants with the most clearances

Product code NFO

Applicants holding the most 510(k) clearances under product code NFO
Applicant	Clearances
Carol Cole Company dba NuFACE	7
Carol Cole Company	4
Micro Current Technology, Inc.	4
Xtreem Pulse	4
YA-Man Ltd.	3
BTL Industries, Inc	2
Foreo Inc	2
Johari Digital Healthcare, Ltd.	2
Li-Tek Electronic Technology Corporation	2
Shenzhen Siken 3D Technology Development Co., Ltd.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 62 companies shown, in name order