Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODELS EMS 5.0, EMS 5.1

K-Number: K072795 · 2007-11-27

ApplicantKoalaty Products, Inc.
Decision Date2007-11-27
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODELS EMS 5.0, EMS 5.1 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 2007-11-27 under 510(k) number K072795. 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 EMS 5.0, EMS 5.1?

MODELS EMS 5.0, EMS 5.1 is a medical device that received FDA 510(k) clearance on 2007-11-27. The listed applicant is Koalaty Products, Inc.. The 510(k) number is K072795.

When did MODELS EMS 5.0, EMS 5.1 receive FDA 510(k) clearance?

MODELS EMS 5.0, EMS 5.1 received FDA 510(k) clearance on 2007-11-27, under 510(k) number K072795.

Who is the listed applicant for MODELS EMS 5.0, EMS 5.1?

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 EMS 5.0, EMS 5.1?

The FDA product code for MODELS EMS 5.0, EMS 5.1 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 3000K080661MODELS TENS 7000, EMS 7500 AND TWIN STIM

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

View on FDA Database →

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

↑