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Stimulator, Muscle, Powered, For Muscle Conditioning

FDA product code NGX · Class 2 · Physical Medicine

1,037
Registered devices
99
Adverse events
3
Recalls
163
510(k) clearances

Devices with this code

Well-Life — WELL-LIFE HEALTHCARE LTD.TENSnet 3MT — CLINICAL HEALTH SERVICES, INC.Slendertone Abs 5 — BIO-MEDICAL RESEARCH LIMITEDFamidoc — FAMIDOC USA, INC.AUVON — Shenzhen Yuwen E-Commerce Co., Ltd.iSTIM — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.MASTOGO — Hong Qiangxing (Shen Zhen) Electronics LimitedTENS 7000 — COMPASS HEALTH BRANDS CORP.PURE ENRICHMENT — BEAR DOWN CONSULTINGTrueStim — Hi-Dow International IncorporatedePower® T2 DIGITAL TENS — CLINICAL HEALTH SERVICES, INC.AUVON — Shenzhen Yuwen E-Commerce Co., Ltd.No — Shenzhen Jian Feng Electronic Technology Co., Ltd.N/A — Shenzhen Osto Technology Co.,Ltd.AUVON — Shenzhen Yuwen E-Commerce Co., Ltd.Pure Enrichment — HIVOX BIOTEK INC.Enso — Hinge Health, Inc.HiDow, SuperTens — Hi-Dow International IncorporatedCreliver — Shenzhen Osto Technology Co.,Ltd.PRO-TECH — Hi-Dow International IncorporatedAUVON — Shenzhen Yuwen E-Commerce Co., Ltd.AUVON — Shenzhen Yuwen E-Commerce Co., Ltd.AUVON — Shenzhen Yuwen E-Commerce Co., Ltd.GEM-STIM — GEMORE TECHNOLOGY CO., LTD.

Recent recalls

DateFirmReason
2021-01-13BEMER INT. AGThere potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of
2013-05-23Pinook-UsaFailure to submit a premarket submission and gain approval of a medical device.
2013-05-23Pinook-UsaFailure to submit a premarket submission and gain approval of a medical device.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.