TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)

FDA 510(k) K220283 · Hong Qiangxing (Shenzhen) Electronics Limited

Substantially Equivalent

510(k) numberK220283

Submission

Device name
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
Applicant
Hong Qiangxing (Shenzhen) Electronics Limited
Shenzhen, CN
Received
February 1, 2022
Decision date
May 2, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J…NUH · Traditional Shenzhen Osto Medical Technology Co.,Ltd09/06/2026SE
K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)NUH · Traditional Shenzhen Dongdixin Technology Co., Ltd.06/26/2026SE
K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)NUH · Traditional Hivox Biotek, Inc.06/16/2026SE
K253896TENS/EMS device (GUSE01)NUH · Traditional Globalcare Medical Technology Co., Ltd.03/04/2026SE
K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)NUH · Traditional Shenzhen Jiantuo Electronics Co., Ltd.12/31/2025SE
K253740Tens&Ems (HZ9151B, HZ9151C, HZ9151D)NUH · Traditional Hong Qiangxing (Shenzhen) Electronics Limited12/23/2025SE
K251958VEINOPLUS BackNUH · Traditional Dynapulse Medical12/23/2025SE
K252688Transcutaneous Electrical Nerve Stimulator (RJTENS-2)NUH · Traditional Bozhou Rongjian Medical Appliance Co., Ltd.11/24/2025SE
K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special Everyway Medical Instruments Co.,Ltd11/21/2025SE
K243131Triathlon ProNUH · Traditional Sigma Biomedical11/07/2025SE

More from Sigma Biomedical

510(k)DeviceDecision
K253740Tens&Ems (HZ9151B, HZ9151C, HZ9151D)NUH · Traditional 12/23/2025SE
K220152TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)NUH · Traditional 04/19/2022SE
K220150TENS & PMS (Model: SM9126)NUH · Traditional 02/17/2022SE
K201354TENS & PMSNGX · Traditional 12/11/2020SE
K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)NUH · Traditional 12/02/2019SE
K183154SM ElectrodesGXY · Traditional 03/26/2019SE
K133108Fit BeltNGX · Traditional 08/05/2014SE
K121719SM TENS & PMSNGX · Traditional 05/10/2013SE

Questions and answers

When was TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) cleared by the FDA?

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) (K220283) received a 510(k) decision of Substantially Equivalent on May 2, 2022, 90 days after the submission was received.

What is the product code of K220283?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.