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FDA 510(k)

TENS STIMULATOR, MODELS 2800 AND 3000

K-Number: K102014 · 2010-08-31

ApplicantKoalaty Products, Inc.
Decision Date2010-08-31
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS STIMULATOR, MODELS 2800 AND 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Koalaty Products, Inc.. It received FDA 510(k) clearance on 2010-08-31 under 510(k) number K102014. 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 TENS STIMULATOR, MODELS 2800 AND 3000?

TENS STIMULATOR, MODELS 2800 AND 3000 is a medical device that received FDA 510(k) clearance on 2010-08-31. The listed applicant is Koalaty Products, Inc.. The 510(k) number is K102014.

When did TENS STIMULATOR, MODELS 2800 AND 3000 receive FDA 510(k) clearance?

TENS STIMULATOR, MODELS 2800 AND 3000 received FDA 510(k) clearance on 2010-08-31, under 510(k) number K102014.

Who is the listed applicant for TENS STIMULATOR, MODELS 2800 AND 3000?

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

What is the FDA product code for TENS STIMULATOR, MODELS 2800 AND 3000?

The FDA product code for TENS STIMULATOR, MODELS 2800 AND 3000 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 Koalaty Products, 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.

K080661MODELS TENS 7000, EMS 7500 AND TWIN STIMK072795MODELS EMS 5.0, EMS 5.1

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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