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FDA 510(k)

PRO TENS, MODEL WL-240 RX

K-Number: K080304 · 2008-06-20

ApplicantWell-Life Healthcare Limited
Decision Date2008-06-20
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PRO TENS, MODEL WL-240 RX 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 2008-06-20 under 510(k) number K080304. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO TENS, MODEL WL-240 RX?

PRO TENS, MODEL WL-240 RX is a medical device that received FDA 510(k) clearance on 2008-06-20. The listed applicant is Well-Life Healthcare Limited. The 510(k) number is K080304.

When did PRO TENS, MODEL WL-240 RX receive FDA 510(k) clearance?

PRO TENS, MODEL WL-240 RX received FDA 510(k) clearance on 2008-06-20, under 510(k) number K080304.

Who is the listed applicant for PRO TENS, MODEL WL-240 RX?

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 PRO TENS, MODEL WL-240 RX?

The FDA product code for PRO TENS, MODEL WL-240 RX is GZJ.

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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

View all 20 devices →

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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