NGX · Stimulator, Muscle, Powered, For Muscle Conditioning

Device class

Class II

Regulation 890.5850

Total clearances

2020-01-22 → 2026-08-13

Last 12 months

Unique sponsors

Definition

What is Stimulator, Muscle, Powered, For Muscle Conditioning

A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.

Classification details

Medical specialty

Physical Medicine

Review panel

Regulation number

890.5850

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
Changsha Anxiang Medical Technology Co., Ltd.	5	0	2025-07-30
Guangzhou Xinbo Electronic Co., Ltd.	4	0	2024-05-16
Zimmer Medizinsysteme GmbH	4	1	2026-01-16
Sofwave Medical, Ltd.	3	0	2025-07-02
Xbody Hungary Kft.	2	0	2025-05-30
Actegy , Ltd.	2	0	2021-12-17
Johari Digital Healthcare Limited	2	0	2022-12-03
Guangzhou Longest Science & Technology Co., Ltd.	2	0	2020-10-08
Miha Bodytec GmbH	2	0	2022-10-07
Bemer Int AG	2	0	2023-06-09
Shenzhen Hengbosi Industrial Co., Ltd.	1	0	2024-01-08
Shenzhen Osto Technology Company Limited	1	0	2021-12-13
Hebei JT Medical Co., Ltd.	1	0	2024-04-24
Nanjing Vishee Medical Technology Co., Ltd.	1	0	2023-03-09
Beijing Adss Development Co., Ltd.	1	0	2023-07-07
Eywa Srl	1	0	2025-05-15
Aura Wellness, LLC	1	0	2023-08-22
Lutronic Corporation	1	0	2022-10-14
Zhengzhou PZ Laser Slim Technology Co., Ltd.	1	0	2025-05-19
ShenB Co., Ltd.	1	1	2026-04-10
Medical Cables S.L.	1	0	2022-08-25
Firstkind Limited	1	0	2020-05-28
Ofan Intelligent Technology (Guangzhou) Co. , Ltd.	1	0	2024-09-17
Bios S.R.L.	1	0	2020-12-31
El.En S.P.A.	1	0	2023-12-19

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	Physical medicine modality; electrical stimulation for muscle conditioning
E0747	HCPCS	Osteogenesis stimulator, electrical, non-invasive, other than spinal applications ✓ CMS-verified description	Medium	Durable medical equipment for electrical stimulation device

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-13	K253790	Beijing Winkonlaser Technology Limited	High Intensity Focused Electromagnetic Stimulation Device (FE60)
2026-04-10	K253926	ShenB Co., Ltd.	Diacore
2026-03-12	K253636	Termosalud S.L.	Zionic Pro Max (EMS)
2026-01-16	K253408	Zimmer Medizinsysteme GmbH	CoolTone
2025-12-09	K252154	Guangzhou Longest Medical Technology Co., Ltd.	Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)
2025-11-06	K253478	Motive Health, Inc.	Motive Muscle Stimulator for Lower Back (OT01-1003)
2025-08-28	K251594	Syrma Johari Medtech Limited	truFlex
2025-07-30	K251706	Changsha Anxiang Medical Technology Co., Ltd.	TENS and EMS Unit
2025-07-14	K251378	Zimmer Medizinsysteme GmbH	CoolTone
2025-07-02	K251746	Sofwave Medical, Ltd.	Pure Impact
2025-06-13	K250759	Changsha Anxiang Medical Technology Co., Ltd.	3 in 1 TENS UNIT
2025-05-30	K242926	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA
2025-05-19	K250038	Zhengzhou PZ Laser Slim Technology Co., Ltd.	Muscle Stimulator Device (PZ-100)
2025-05-15	K243165	Eywa Srl	Limfa Therapy System (Limfa Therapy)
2025-04-18	K250146	Sofwave Medical, Ltd.	SofWave System
2025-03-12	K243763	Changsha Anxiang Medical Technology Co., Ltd.	Wireless TENS & EMS Unit
2025-02-25	K241601	Cpmt Laser (Canadian Pioneer Medical Technology Corporation)	EMS (FlexPulse, MagnaCore, Magnetika)
2025-02-10	K243511	Changsha Anxiang Medical Technology Co., Ltd.	OTC TENS & EMS Unit
2025-01-16	K233770	Pepper Interactive, Inc.	Pepper EMS Training System
2024-12-18	K242787	Changsha Anxiang Medical Technology Co., Ltd.	Tens & Ems Device (TU1080)
2024-11-25	K232982	Shandong Huamei Technology Co., Ltd.	EMS Sculpt Machine
2024-09-17	K242186	Ofan Intelligent Technology (Guangzhou) Co. , Ltd.	Neo Sculptor (OF-NEO001)
2024-08-07	K241685	Sofwave Medical, Ltd.	SofWave System
2024-07-21	K240347	Zimmer Medizinsysteme GmbH	PTG-05
2024-05-16	K230711	Guangzhou Xinbo Electronic Co., Ltd.	Pain Therapy Device(Model: P.T.S-X)