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FDA 510(k)

Scrambler Therapy Technology (Model ST-5A)

K-Number: K201458 · 2020-12-23

ApplicantDelta International Services & Logistics S.R.L
Decision Date2020-12-23
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Scrambler Therapy Technology (Model ST-5A) is a medical device manufactured by Delta International Services & Logistics S.R.L. It received FDA 510(k) clearance on 2020-12-23 under approval number K201458. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Scrambler Therapy Technology (Model ST-5A)?

Scrambler Therapy Technology (Model ST-5A) is a medical device that received FDA 510(k) clearance on 2020-12-23. It is manufactured by Delta International Services & Logistics S.R.L. The 510(k) number is K201458.

When was Scrambler Therapy Technology (Model ST-5A) approved by the FDA?

Scrambler Therapy Technology (Model ST-5A) received FDA 510(k) clearance on 2020-12-23, under approval number K201458.

What company makes Scrambler Therapy Technology (Model ST-5A)?

Scrambler Therapy Technology (Model ST-5A) is manufactured by Delta International Services & Logistics S.R.L.

What is the FDA product code for Scrambler Therapy Technology (Model ST-5A)?

The FDA product code for Scrambler Therapy Technology (Model ST-5A) is GZJ.

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Related PubMed Literature

PMID: 40678717 Bridging AI innovation and healthcare: scalable clinical validation methods for voice biomarkers. Frontiers in digital health (2025) PMID: 40417352 Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law. Frontiers in medical technology (2025) PMID: 39993988 [Analysis of Brain-Computer Interface Technology in the Medical Field and the Regulation of the US FDA]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

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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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