FDA 510(k)

Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)

K-Number: K261574 · 2026-10-16

ApplicantHong Qiangxing (Shenzhen) Electronics Limited

Decision Date2026-10-16

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) is the device name listed in this FDA 510(k) record. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2026-10-16 under 510(k) number K261574. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)?

Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) is a medical device that received FDA 510(k) clearance on 2026-10-16. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K261574.

When did Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) receive FDA 510(k) clearance?

Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) received FDA 510(k) clearance on 2026-10-16, under 510(k) number K261574.

Who is the listed applicant for Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)?

The FDA 510(k) record lists Hong Qiangxing (Shenzhen) Electronics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)?

The FDA product code for Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) is NUH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Hong Qiangxing (Shenzhen) Electronics Limited as applicant

K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)K220283TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)K220152TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)K220150TENS & PMS (Model: SM9126)K201354TENS & PMS K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)

View all 9 devices →

Related Devices (Code: NUH)

K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,Ltd K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K251958VEINOPLUS BackDynapulse Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.