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FDA 510(k)

LIFECARE COMPACT TENS DEVICE

K-Number: K003369 · 2001-03-08

ApplicantLifecare , Ltd.
Decision Date2001-03-08
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LIFECARE COMPACT TENS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Lifecare , Ltd.. It received FDA 510(k) clearance on 2001-03-08 under 510(k) number K003369. 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 LIFECARE COMPACT TENS DEVICE?

LIFECARE COMPACT TENS DEVICE is a medical device that received FDA 510(k) clearance on 2001-03-08. The listed applicant is Lifecare , Ltd.. The 510(k) number is K003369.

When did LIFECARE COMPACT TENS DEVICE receive FDA 510(k) clearance?

LIFECARE COMPACT TENS DEVICE received FDA 510(k) clearance on 2001-03-08, under 510(k) number K003369.

Who is the listed applicant for LIFECARE COMPACT TENS DEVICE?

The FDA 510(k) record lists Lifecare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFECARE COMPACT TENS DEVICE?

The FDA product code for LIFECARE COMPACT TENS DEVICE is GZJ.

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.

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Other records listing Lifecare , Ltd. 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.

K183110LIVIAK163153Livia

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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