FDA 510(k)

TENS

K-Number: K850006 · 1985-12-20

Decision Date1985-12-20

Product Code

DecisionSubstantially Equivalent for Some Indications

Device Summary

TENS is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Elektromedizin GmbH. It received FDA 510(k) clearance on 1985-12-20 under 510(k) number K850006. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the TENS?

TENS is a medical device that received FDA 510(k) clearance on 1985-12-20. The listed applicant is Zimmer Elektromedizin GmbH. The 510(k) number is K850006.

When did TENS receive FDA 510(k) clearance?

TENS received FDA 510(k) clearance on 1985-12-20, under 510(k) number K850006.

Who is the listed applicant for TENS?

The FDA 510(k) record lists Zimmer Elektromedizin GmbH as the applicant. This does not by itself establish the device manufacturer.

Related PubMed Literature

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.

PMID: 34499554Focal High-Intensity Focused Ultrasound Ablation of the Prostate.Journal of endourology ()PMID: 29060903Development of evaluation methods for the approval and review of Intense pulsed light (IPL).Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference ()

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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.