Avail

FDA 510(k) K172079 · Omron Healthcare, Inc.

Substantially Equivalent

510(k) numberK172079

Submission

Device name
Avail
Applicant
Omron Healthcare, Inc.
Lake Forest, IL, US
Received
July 10, 2017
Decision date
October 19, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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

Other 510(k)s with product code NUH

510(k)DeviceApplicantDecision
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
K261929Upper Arm Blood pressure monitor (BP7155D)DXN · Special 09/10/2026SE
K202228Omron Model BP7900 Blood Pressure Monitor + EKGDXN · Traditional 04/01/2021SE
K183215Focus TENS Therapy, Model PM710-M/-LNUH · Traditional 09/07/2019SE
K190693HEM-6410T-ZL Wrist Blood Pressure MonitorDXN · Special 04/17/2019SE
K182579Omron Model BP7900 Blood Pressure Monitor + EKGDXN · Traditional 03/14/2019SE
K182120Maxpower ReliefNUH · Traditional 01/10/2019SE
K182481HEM-6410T-ZM Wrist Blood Pressure MonitorDXN · Traditional 11/09/2018SE
K181992Heat Pain ProNUH · Traditional 11/09/2018SE
K182166Wrist Blood Pressure Monitor Model BP4350DXN · Traditional 11/08/2018SE
K182127Wrist Blood Pressure Monitor Model BP6100DXN · Traditional 11/02/2018SE

Questions and answers

When was Avail cleared by the FDA?

Avail (K172079) received a 510(k) decision of Substantially Equivalent on October 19, 2017, 101 days after the submission was received.

What is the product code of K172079?

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