NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Device class

Class II

Regulation 882.5890

Total clearances

2020-07-31 → 2026-07-23

Last 12 months

Unique sponsors

Classification details

Medical specialty

Neurology

Review panel

Regulation number

882.5890

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Xtreem Pulse	3	0	2025-03-06
Ya-Man, Ltd.	3	1	2025-10-29
Foreo, Inc.	2	0	2024-05-13
Carol Cole Company Dba Nuface	2	0	2021-02-24
BTL Industries, Inc.	2	0	2024-12-13
Micro Current Technology, Inc.	2	0	2025-07-18
ShenB Co., Ltd.	1	1	2025-09-18
21 Equipment S.R.L.	1	0	2023-10-19
Ziip, Inc.	1	0	2021-09-23
Johari Digital Healthcare Limited	1	0	2023-04-27
Shenzhen Siken 3D Technology Development Co., Ltd.	1	1	2025-12-23
Shenzhen Jianchao Intelligent Technology Co., Ltd.	1	1	2025-10-09
Geske Beauty Tech GmbH	1	0	2025-05-23
Shenzhen DJ Medical Equipment Co., Ltd.	1	0	2021-11-05
EMA Aesthetics , Ltd.	1	0	2025-04-01
Aura Medical, LLC	1	1	2025-12-23
Shenzhen Dachi Communication Co., Ltd.	1	0	2025-07-10
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.	1	1	2026-06-03
Avazzia, Inc.	1	0	2021-04-27
Shenzhen Aozemei Technology Co., Ltd.	1	0	2024-12-19
A-1 Engineering	1	1	2025-09-03
Shenzhen Kaiyan Medical Equipment Co., Ltd.	1	1	2026-07-23
Theragun, Inc.	1	0	2021-09-29
Premier North America, Inc.	1	0	2022-02-24
Carole Cole Company	1	0	2021-02-19

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
97014	CPT	—	Medium	Transcutaneous electrical nerve stimulation (TENS) application; aesthetic TENS falls here

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-23	K253932	Shenzhen Kaiyan Medical Equipment Co., Ltd.	FACEGYM Pro Device (HD-109)
2026-06-03	K260179	Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.	VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
2026-05-28	K260895	Guangxi Ulike Medical Technology Co., Ltd.	Ulike Clear Zero (YC10 BU)
2026-05-08	K252621	El Global Trade, Ltd.	DeepSkin (DEP100)
2025-12-23	K252187	Aura Medical, LLC	Aura Glide (FC40)
2025-12-23	K252146	Shenzhen Siken 3D Technology Development Co., Ltd.	Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
2025-10-29	K250618	Ya-Man, Ltd.	Medi Lift Essential Eye Mask
2025-10-17	K250227	Shenzhen Qianyu Technology Co., Ltd.	JOVS Electric Stimulation Beauty Device (JE2)
2025-10-12	K251034	Shenzhen Nuon Medical Equipment Co., Ltd.	Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)
2025-10-09	K252553	Shenzhen Jianchao Intelligent Technology Co., Ltd.	Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
2025-09-18	K251649	ShenB Co., Ltd.	Sunny Plus (Sunny)
2025-09-03	K251909	A-1 Engineering	NeurotriS (SX2500); NeurotriS (SX3800)
2025-07-18	K252218	Micro Current Technology, Inc.	MF SC GEN2 Facial Toning System
2025-07-10	K244004	Shenzhen Dachi Communication Co., Ltd.	Microcurrent Facial Device (CEC101, EE0101, EEI101)
2025-05-23	K250361	Geske Beauty Tech GmbH	SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1
2025-04-01	K243072	EMA Aesthetics , Ltd.	Préime DermaFacial (MicroT)
2025-03-06	K243587	Xtreem Pulse, LLC	PureLift GLOW
2025-02-10	K243063	Raja Trading Company, Inc.	Myolight Microcurrent Handpiece
2025-02-03	K243393	Shenzhen Ulike Smart Electronics Co., Ltd.	JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)
2025-01-16	K244048	Ya-Man, Ltd.	Medi Lift Mask
2024-12-19	K243430	Shenzhen Aozemei Technology Co., Ltd.	Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
2024-12-13	K242532	BTL Industries, Inc.	BTL-785BNF-E
2024-06-27	K240564	Carol Cole Company Dba Nuface®	NuFACE® FIX+
2024-05-13	K232242	Foreo, Inc.	BEAR 2 Body
2024-02-12	K233667	Body Trim Industrial Co., Ltd.	Facial Toning device (UIC-189); Facial Toning device (UIC-589)