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)

COMFORTRON II (TENS)

K-Number: K902948 · 1990-12-17

ApplicantM. D. Products
Decision Date1990-12-17
Product CodeLWM
DecisionSubstantially Equivalent

Device Summary

COMFORTRON II (TENS) is the device name listed in this FDA 510(k) record. The listed applicant is M. D. Products. It received FDA 510(k) clearance on 1990-12-17 under 510(k) number K902948. The device is classified under product code LWM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORTRON II (TENS)?

COMFORTRON II (TENS) is a medical device that received FDA 510(k) clearance on 1990-12-17. The listed applicant is M. D. Products. The 510(k) number is K902948.

When did COMFORTRON II (TENS) receive FDA 510(k) clearance?

COMFORTRON II (TENS) received FDA 510(k) clearance on 1990-12-17, under 510(k) number K902948.

Who is the listed applicant for COMFORTRON II (TENS)?

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

What is the FDA product code for COMFORTRON II (TENS)?

The FDA product code for COMFORTRON II (TENS) is LWM.

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 M. D. Products 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.

K884586COMFORTRON DENTAL ANESTHESIA APPARATUSK871227LES RAD FILTER

Related Devices (Code: LWM)

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.

K193570Dental Pain EraserSynapse DentalK192429Dental Pain EraserSynapse DentalK182947Dental Pain EraserSynapse Dental, LLCK011001TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEMSatelecK9353043M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 86703M CompanyK9350853M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS3M Company

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.

↑