K221425 is an FDA 510(k) clearance for the Primary Relief. Classified as Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief (product code NHI), Class II - Special Controls.
Submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on September 13, 2022 after a review of 120 days - within the typical 510(k) review window.
This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.
View all Dyansys, Inc. devices
NCT03750357
Completed
Interventional
Industry-sponsored
Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Post Operative Pain Solution(POPS) - Cardiac Surgery
Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Acute Pain Management Post Cardiac Surgery
| Condition studied |
Post Operative Pain; Midline Sternotomy Incision |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Rohini M Balaji, MBBS., DNB |
| Sponsor |
DyAnsys, Inc.
(industry)
|
Started 2018-10-11
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Primary completion 2018-11-17
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Completed 2018-12-17
Primary outcome
PAIN Relief by physical examination by HCP
Study completed - no results published.
This trial concluded in 2018 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov