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FDA 510(k)

ProMedTek Model C1400 Shortwave Diathermy Device

K-Number: K162240 · 2016-11-17

ApplicantPromedtek, Inc.
Decision Date2016-11-17
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ProMedTek Model C1400 Shortwave Diathermy Device is a medical device manufactured by Promedtek, Inc.. It received FDA 510(k) clearance on 2016-11-17 under approval number K162240. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProMedTek Model C1400 Shortwave Diathermy Device?

ProMedTek Model C1400 Shortwave Diathermy Device is a medical device that received FDA 510(k) clearance on 2016-11-17. It is manufactured by Promedtek, Inc.. The 510(k) number is K162240.

When was ProMedTek Model C1400 Shortwave Diathermy Device approved by the FDA?

ProMedTek Model C1400 Shortwave Diathermy Device received FDA 510(k) clearance on 2016-11-17, under approval number K162240.

What company makes ProMedTek Model C1400 Shortwave Diathermy Device?

ProMedTek Model C1400 Shortwave Diathermy Device is manufactured by Promedtek, Inc..

What is the FDA product code for ProMedTek Model C1400 Shortwave Diathermy Device?

The FDA product code for ProMedTek Model C1400 Shortwave Diathermy Device is IMJ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 40408133 A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study. Journal of medical Internet research (2025)

Related Devices (Code: IMJ)

K161862ThermoProZimmer Medizinsysteme GmbH K153456Megapulse III Shortwave DiathermyAccelerated Care Plus K173300ViaTherm BOOSTViatherm Therapeutics, LLC K182363BTL-703BTL Industries, Inc. K223620Reprieve by RegenesisTMRegenesis Biomedical, Inc. K250376ViVYViatherm Therapeutics, LLC

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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