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FDA 510(k)

OTC TENS Device, Model PTS-IV

K-Number: K161537 · 2016-10-13

ApplicantCounter Scientific Development (Gz), Ltd.
Decision Date2016-10-13
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OTC TENS Device, Model PTS-IV is a medical device manufactured by Counter Scientific Development (Gz), Ltd.. It received FDA 510(k) clearance on 2016-10-13 under approval number K161537. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTC TENS Device, Model PTS-IV?

OTC TENS Device, Model PTS-IV is a medical device that received FDA 510(k) clearance on 2016-10-13. It is manufactured by Counter Scientific Development (Gz), Ltd.. The 510(k) number is K161537.

When was OTC TENS Device, Model PTS-IV approved by the FDA?

OTC TENS Device, Model PTS-IV received FDA 510(k) clearance on 2016-10-13, under approval number K161537.

What company makes OTC TENS Device, Model PTS-IV?

OTC TENS Device, Model PTS-IV is manufactured by Counter Scientific Development (Gz), Ltd..

What is the FDA product code for OTC TENS Device, Model PTS-IV?

The FDA product code for OTC TENS Device, Model PTS-IV is NUH.

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Other Devices by Counter Scientific Development (Gz), Ltd.

K150277Pain Therapy System, Model PTS-II

Related Devices (Code: NUH)

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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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