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FDA 510(k)

COMFORTRON PT (TENS)

K-Number: K911066 · 1992-02-07

ApplicantM. D. Supply, Inc.
Decision Date1992-02-07
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COMFORTRON PT (TENS) is the device name listed in this FDA 510(k) record. The listed applicant is M. D. Supply, Inc.. It received FDA 510(k) clearance on 1992-02-07 under 510(k) number K911066. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORTRON PT (TENS)?

COMFORTRON PT (TENS) is a medical device that received FDA 510(k) clearance on 1992-02-07. The listed applicant is M. D. Supply, Inc.. The 510(k) number is K911066.

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

COMFORTRON PT (TENS) received FDA 510(k) clearance on 1992-02-07, under 510(k) number K911066.

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

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

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

The FDA product code for COMFORTRON PT (TENS) is GZI.

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 M. D. Supply, 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.

K925821COMFORTRONK862092COMFORTRON

Related Devices (Code: GZI)

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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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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