OTC TENS Device, Model PTS-IV
K-Number: K161537 · 2016-10-13
Device Summary
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. The listed applicant is Counter Scientific Development (Gz), Ltd.. The 510(k) number is K161537.
When did OTC TENS Device, Model PTS-IV receive FDA 510(k) clearance?
OTC TENS Device, Model PTS-IV received FDA 510(k) clearance on 2016-10-13, under 510(k) number K161537.
Who is the listed applicant for OTC TENS Device, Model PTS-IV?
The FDA 510(k) record lists Counter Scientific Development (Gz), Ltd. as the applicant. This does not by itself establish the device manufacturer.
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.
Other records listing Counter Scientific Development (Gz), Ltd. 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: NUH)
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.