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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 the device name listed in this FDA 510(k) record. The listed applicant is Delta International Services & Logistics S.R.L. It received FDA 510(k) clearance on 2020-12-23 under 510(k) 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. The listed applicant is Delta International Services & Logistics S.R.L. The 510(k) number is K201458.

When did Scrambler Therapy Technology (Model ST-5A) receive FDA 510(k) clearance?

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

Who is the listed applicant for Scrambler Therapy Technology (Model ST-5A)?

The FDA 510(k) record lists Delta International Services & Logistics S.R.L as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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