← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
NFO — Stimulator, Transcutaneous Electrical, Aesthetic Purposes
DEVICE CLASS
Class II
REGULATION
21 CFR 882.5890
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
21
510(K)/PMA CLEARANCES
510k: 21
0
RECALL ENTRIES
Recent clearances
K260179Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. · 510k2026-06-03
K260895Guangxi Ulike Medical Technology Co., Ltd. · 510k2026-05-28
K252621El Global Trade, Ltd. · 510k2026-05-08
K252187Aura Medical, LLC · 510k2025-12-23
K252146Shenzhen Siken 3D Technology Development Co., Ltd. · 510k2025-12-23
K250618Ya-Man, Ltd. · 510k2025-10-29
K250227Shenzhen Qianyu Technology Co., Ltd. · 510k2025-10-17
K251034Shenzhen Nuon Medical Equipment Co., Ltd. · 510k2025-10-12
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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