FDA 510(k)

WELL-TENS

K-Number: K002874 · 2001-07-27

Decision Date2001-07-27

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

WELL-TENS is the device name listed in this FDA 510(k) record. The listed applicant is Well-Life Consultant. It received FDA 510(k) clearance on 2001-07-27 under 510(k) number K002874. 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 WELL-TENS?

WELL-TENS is a medical device that received FDA 510(k) clearance on 2001-07-27. The listed applicant is Well-Life Consultant. The 510(k) number is K002874.

When did WELL-TENS receive FDA 510(k) clearance?

WELL-TENS received FDA 510(k) clearance on 2001-07-27, under 510(k) number K002874.

Who is the listed applicant for WELL-TENS?

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

What is the FDA product code for WELL-TENS?

The FDA product code for WELL-TENS is GZJ.

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 miniSublimed K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046Electrical 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.