FDA 510(k)

Human Tecar HCR 1002

K-Number: K181211 · 2018-09-10

Decision Date2018-09-10

Product CodePBX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Human Tecar HCR 1002 is the device name listed in this FDA 510(k) record. The listed applicant is Unibell S.R.L. It received FDA 510(k) clearance on 2018-09-10 under 510(k) number K181211. 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 Human Tecar HCR 1002?

Human Tecar HCR 1002 is a medical device that received FDA 510(k) clearance on 2018-09-10. The listed applicant is Unibell S.R.L. The 510(k) number is K181211.

When did Human Tecar HCR 1002 receive FDA 510(k) clearance?

Human Tecar HCR 1002 received FDA 510(k) clearance on 2018-09-10, under 510(k) number K181211.

Who is the listed applicant for Human Tecar HCR 1002?

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

What is the FDA product code for Human Tecar HCR 1002?

The FDA product code for Human Tecar HCR 1002 is PBX.

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.

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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.