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FDA 510(k)

Well-Life TENS/EMS/Heating Stimulator

K-Number: K213091 · 2022-02-19

ApplicantWell-Life Healthcare Limited
Decision Date2022-02-19
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Well-Life TENS/EMS/Heating Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2022-02-19 under 510(k) number K213091. 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 Well-Life TENS/EMS/Heating Stimulator?

Well-Life TENS/EMS/Heating Stimulator is a medical device that received FDA 510(k) clearance on 2022-02-19. The listed applicant is Well-Life Healthcare Limited. The 510(k) number is K213091.

When did Well-Life TENS/EMS/Heating Stimulator receive FDA 510(k) clearance?

Well-Life TENS/EMS/Heating Stimulator received FDA 510(k) clearance on 2022-02-19, under 510(k) number K213091.

Who is the listed applicant for Well-Life TENS/EMS/Heating Stimulator?

The FDA 510(k) record lists Well-Life Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Well-Life TENS/EMS/Heating Stimulator?

The FDA product code for Well-Life TENS/EMS/Heating Stimulator 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.

NCT07659314Post Operative Pain and Vagal StimulationNOT_YET_RECRUITING

Other records listing Well-Life Healthcare Limited as applicant

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.

K251760Well-Life Incontinence Stimulation System (WL-2405i(P))K233054Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus StimulatorK222528Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe ElectrodeK220524Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)K200942Well-Life Garment Electrodes (GM Series)K172809OTC Combo TENS/EMS System

View all 9 devices →

Related Devices (Code: NUH)

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.

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.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS 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.

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