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FDA 510(k)

SPRY TMS Therapy System (0550)

K-Number: K251653 · 2026-02-20

ApplicantSoterix Medical, Inc.
Decision Date2026-02-20
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPRY TMS Therapy System (0550) is a medical device manufactured by Soterix Medical, Inc.. It received FDA 510(k) clearance on 2026-02-20 under approval number K251653. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPRY TMS Therapy System (0550)?

SPRY TMS Therapy System (0550) is a medical device that received FDA 510(k) clearance on 2026-02-20. It is manufactured by Soterix Medical, Inc.. The 510(k) number is K251653.

When was SPRY TMS Therapy System (0550) approved by the FDA?

SPRY TMS Therapy System (0550) received FDA 510(k) clearance on 2026-02-20, under approval number K251653.

What company makes SPRY TMS Therapy System (0550)?

SPRY TMS Therapy System (0550) is manufactured by Soterix Medical, Inc..

What is the FDA product code for SPRY TMS Therapy System (0550)?

The FDA product code for SPRY TMS Therapy System (0550) is OBP.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Other Devices by Soterix Medical, Inc.

K170291IontoDC K191422Neural Navigator K192823MEGA-TMS K233751Milieve (YPS-301BD) K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)

Related Devices (Code: OBP)

K160309Neurosoft TMSTeleemg, LLC K161519NeuroStar TMS Therapy SystemNeuronetics, Inc. K160703NeuroStar TMS Therapy SystemNeuronetics, Inc. K173441Neurosoft TMS (also CloudTMS)Teleemg, LLC K171902Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S

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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