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FDA 510(k)

Transcutaneous Electrical Nerve Stimulator Model: ST-304

K-Number: K221092 · 2022-09-13

ApplicantShenzhen Future Electronic Co., Ltd.
Decision Date2022-09-13
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Transcutaneous Electrical Nerve Stimulator Model: ST-304 is a medical device manufactured by Shenzhen Future Electronic Co., Ltd.. It received FDA 510(k) clearance on 2022-09-13 under approval number K221092. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transcutaneous Electrical Nerve Stimulator Model: ST-304?

Transcutaneous Electrical Nerve Stimulator Model: ST-304 is a medical device that received FDA 510(k) clearance on 2022-09-13. It is manufactured by Shenzhen Future Electronic Co., Ltd.. The 510(k) number is K221092.

When was Transcutaneous Electrical Nerve Stimulator Model: ST-304 approved by the FDA?

Transcutaneous Electrical Nerve Stimulator Model: ST-304 received FDA 510(k) clearance on 2022-09-13, under approval number K221092.

What company makes Transcutaneous Electrical Nerve Stimulator Model: ST-304?

Transcutaneous Electrical Nerve Stimulator Model: ST-304 is manufactured by Shenzhen Future Electronic Co., Ltd..

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator Model: ST-304?

The FDA product code for Transcutaneous Electrical Nerve Stimulator Model: ST-304 is NUH.

Related Clinical Trials

NCT07517172 Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT06816004 Noninvasive Vagal Nerve Stimulation ACTIVE_NOT_RECRUITING NCT07614945 Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia NOT_YET_RECRUITING NCT06127550 taVNS for Letter Learning in Dyslexia SUSPENDED NCT07610655 Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression RECRUITING

Other Devices by Shenzhen Future Electronic Co., Ltd.

K213745Air Compression Therapy Device, model: ST-502 K251662Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507)

Related Devices (Code: NUH)

K162630CP Relief Wand-OTCMid-America Medical Innovations, LLC K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605AWell-Life Healthcare Limited K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd. K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd. K151995Painmaster MCT PatchNewmark, Inc. K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc.

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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