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FDA 510(k)

WELL-LIFE OTC EMS SYSTEM

K-Number: K102786 · 2011-07-01

ApplicantWell-Life Healthcare Limited
Decision Date2011-07-01
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WELL-LIFE OTC EMS SYSTEM 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 2011-07-01 under 510(k) number K102786. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELL-LIFE OTC EMS SYSTEM?

WELL-LIFE OTC EMS SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-01. The listed applicant is Well-Life Healthcare Limited. The 510(k) number is K102786.

When did WELL-LIFE OTC EMS SYSTEM receive FDA 510(k) clearance?

WELL-LIFE OTC EMS SYSTEM received FDA 510(k) clearance on 2011-07-01, under 510(k) number K102786.

Who is the listed applicant for WELL-LIFE OTC EMS SYSTEM?

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 OTC EMS SYSTEM?

The FDA product code for WELL-LIFE OTC EMS SYSTEM is NGX.

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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.

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)K213091Well-Life TENS/EMS/Heating StimulatorK200942Well-Life Garment Electrodes (GM Series)K172809OTC Combo TENS/EMS System

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Related Devices (Code: NGX)

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.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

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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