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FDA 510(k)

Doctor Tecar Plus, Doctor Tecar Smart

K-Number: K221043 · 2023-02-17

Decision Date2023-02-17
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Doctor Tecar Plus, Doctor Tecar Smart is the device name listed in this FDA 510(k) record. The listed applicant is Mectronic Medicale S.R.L.. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K221043. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Doctor Tecar Plus, Doctor Tecar Smart?

Doctor Tecar Plus, Doctor Tecar Smart is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Mectronic Medicale S.R.L.. The 510(k) number is K221043.

When did Doctor Tecar Plus, Doctor Tecar Smart receive FDA 510(k) clearance?

Doctor Tecar Plus, Doctor Tecar Smart received FDA 510(k) clearance on 2023-02-17, under 510(k) number K221043.

Who is the listed applicant for Doctor Tecar Plus, Doctor Tecar Smart?

The FDA 510(k) record lists Mectronic Medicale S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Doctor Tecar Plus, Doctor Tecar Smart?

The FDA product code for Doctor Tecar Plus, Doctor Tecar Smart is PBX.

Other records listing Mectronic Medicale S.R.L. 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.

Related Devices (Code: PBX)

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.

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.