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FDA 510(k)

MODELS TENS 7000, EMS 7500 AND TWIN STIM

K-Number: K080661 · 2008-03-24

ApplicantKoalaty Products, Inc.
Decision Date2008-03-24
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODELS TENS 7000, EMS 7500 AND TWIN STIM 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 2008-03-24 under 510(k) number K080661. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODELS TENS 7000, EMS 7500 AND TWIN STIM?

MODELS TENS 7000, EMS 7500 AND TWIN STIM is a medical device that received FDA 510(k) clearance on 2008-03-24. The listed applicant is Koalaty Products, Inc.. The 510(k) number is K080661.

When did MODELS TENS 7000, EMS 7500 AND TWIN STIM receive FDA 510(k) clearance?

MODELS TENS 7000, EMS 7500 AND TWIN STIM received FDA 510(k) clearance on 2008-03-24, under 510(k) number K080661.

Who is the listed applicant for MODELS TENS 7000, EMS 7500 AND TWIN STIM?

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 MODELS TENS 7000, EMS 7500 AND TWIN STIM?

The FDA product code for MODELS TENS 7000, EMS 7500 AND TWIN STIM is IPF.

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.

K102014TENS STIMULATOR, MODELS 2800 AND 3000K072795MODELS EMS 5.0, EMS 5.1

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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