FDA 510(k)

LIFECARE ARM & LEG PAIN RELIEF SYSTEM

K-Number: K112415 · 2011-10-21

ApplicantEveryway Medical Instruments Co.,Ltd

Decision Date2011-10-21

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

LIFECARE ARM & LEG PAIN RELIEF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2011-10-21 under 510(k) number K112415. 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 LIFECARE ARM & LEG PAIN RELIEF SYSTEM?

LIFECARE ARM & LEG PAIN RELIEF SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-21. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K112415.

When did LIFECARE ARM & LEG PAIN RELIEF SYSTEM receive FDA 510(k) clearance?

LIFECARE ARM & LEG PAIN RELIEF SYSTEM received FDA 510(k) clearance on 2011-10-21, under 510(k) number K112415.

Who is the listed applicant for LIFECARE ARM & LEG PAIN RELIEF SYSTEM?

The FDA 510(k) record lists Everyway Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFECARE ARM & LEG PAIN RELIEF SYSTEM?

The FDA product code for LIFECARE ARM & LEG PAIN RELIEF SYSTEM 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 NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Everyway Medical Instruments Co.,Ltd as applicant

K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 K222488Everyway Analog OTC TENS K213116Everyway Incontinence Stimulation System K202849Everyway Analog OTC TENS, model N103A/N302 K202470Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 K202317Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806

View all 27 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.