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FDA 510(k)

actiTENS mini

K-Number: K252767 · 2026-01-16

ApplicantSublimed
Decision Date2026-01-16
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

actiTENS mini is a medical device manufactured by Sublimed. It received FDA 510(k) clearance on 2026-01-16 under approval 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. It is manufactured by Sublimed. The 510(k) number is K252767.

When was actiTENS mini approved by the FDA?

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

What company makes actiTENS mini?

actiTENS mini is manufactured by Sublimed.

What is the FDA product code for actiTENS mini?

The FDA product code for actiTENS mini is GZJ.

Other Devices by Sublimed

K202159actiTENS

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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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