FDA 510(k)

actiTENS

K-Number: K202159 · 2020-12-22

Decision Date2020-12-22

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

actiTENS is the device name listed in this FDA 510(k) record. The listed applicant is Sublimed. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K202159. 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 actiTENS?

actiTENS is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Sublimed. The 510(k) number is K202159.

When did actiTENS receive FDA 510(k) clearance?

actiTENS received FDA 510(k) clearance on 2020-12-22, under 510(k) number K202159.

Who is the listed applicant for actiTENS?

The FDA 510(k) record lists Sublimed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for actiTENS?

The FDA product code for actiTENS is GZJ.

Other records listing Sublimed 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.

K252767actiTENS mini

Related Devices (Code: GZJ)

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimed K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.