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FDA 510(k)

TEA Device

K-Number: K230526 · 2023-09-14

ApplicantTranstimulation Research, Inc.
Decision Date2023-09-14
Product CodeQHH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TEA Device is a medical device manufactured by Transtimulation Research, Inc.. It received FDA 510(k) clearance on 2023-09-14 under approval number K230526. The device is classified under product code QHH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEA Device?

TEA Device is a medical device that received FDA 510(k) clearance on 2023-09-14. It is manufactured by Transtimulation Research, Inc.. The 510(k) number is K230526.

When was TEA Device approved by the FDA?

TEA Device received FDA 510(k) clearance on 2023-09-14, under approval number K230526.

What company makes TEA Device?

TEA Device is manufactured by Transtimulation Research, Inc..

What is the FDA product code for TEA Device?

The FDA product code for TEA Device is QHH.

Other Devices by Transtimulation Research, Inc.

K243613Patch-TEA (Model TRI-21)

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DEN180057IB-StimInnovative Health Solutions (Ihs), Inc. K202940First Relief v1Dyansys, Inc. K241533NeurAxis IB-Stim (01-1020)Neuraxis K252024NeurAxis IB-Stim (01-1020)Neuraxis K250451NeurAxis IB-Stim (01-1020)Neuraxis

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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