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FDA 510(k)

LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401

K-Number: K040512 · 2004-05-27

ApplicantWell-Life Healthcare, Inc.
Decision Date2004-05-27
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 is the device name listed in this FDA 510(k) record. The listed applicant is Well-Life Healthcare, Inc.. It received FDA 510(k) clearance on 2004-05-27 under 510(k) number K040512. 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 LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401?

LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 is a medical device that received FDA 510(k) clearance on 2004-05-27. The listed applicant is Well-Life Healthcare, Inc.. The 510(k) number is K040512.

When did LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 receive FDA 510(k) clearance?

LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 received FDA 510(k) clearance on 2004-05-27, under 510(k) number K040512.

Who is the listed applicant for LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401?

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

What is the FDA product code for LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401?

The FDA product code for LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 is GZJ.

Related Clinical Trials

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Other records listing Well-Life Healthcare, Inc. 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.

K033857T-TECH DIGITAL, MODEL WL-22XXA SERIESK030537DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205BK020020THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)K021359DIGI-PRO TENS MODEL WL-2203 AND WL-2205K020314DIGI-PRO TENS, MODEL WL-2204 AND WL-2205

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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