FDA 510(k)

actiTENS mini

K-Number: K252767 · 2026-01-16

Decision Date2026-01-16

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

actiTENS mini is the device name listed in this FDA 510(k) record. The listed applicant is Sublimed. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K252767. 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 mini?

actiTENS mini is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Sublimed. The 510(k) number is K252767.

When did actiTENS mini receive FDA 510(k) clearance?

actiTENS mini received FDA 510(k) clearance on 2026-01-16, under 510(k) number K252767.

Who is the listed applicant for actiTENS mini?

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 mini?

The FDA product code for actiTENS mini 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.

K202159actiTENS

Related Devices (Code: GZJ)

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.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 K222879Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)Wuxi Jiajian Medical Instrument Co., Ltd.

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.