Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

THAIRAPY SYSTEM

K-Number: K936121 · 1994-08-02

ApplicantAmerican Biosystems, Inc.
Decision Date1994-08-02
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THAIRAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Biosystems, Inc.. It received FDA 510(k) clearance on 1994-08-02 under 510(k) number K936121. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THAIRAPY SYSTEM?

THAIRAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1994-08-02. The listed applicant is American Biosystems, Inc.. The 510(k) number is K936121.

When did THAIRAPY SYSTEM receive FDA 510(k) clearance?

THAIRAPY SYSTEM received FDA 510(k) clearance on 1994-08-02, under 510(k) number K936121.

Who is the listed applicant for THAIRAPY SYSTEM?

The FDA 510(k) record lists American Biosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THAIRAPY SYSTEM?

The FDA product code for THAIRAPY SYSTEM is BYI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Biosystems, Inc. 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.

K993629ABI VEST AIRWAY CLEARANCE SYSTEMK965192THAIRAPY VEST SYSTEMK884098THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101

Related Devices (Code: BYI)

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.

K252849AffloVest® Mobile Airway Clearance TherapyTactile MedicalK250860BreatheBand® (Model 1000)Exemplar Medical, LLCK242063LibAirty Airway Clearance SystemSynchrony Medical , Ltd.K240959Respiratory Muscle TrainerChongqing Moffy Innovation Technology Co., Ltd.K233441The Vest APX System (PVAPX1)Baxter Healthcare CorportationK222496Electromed SmartVest Airway Clearance SystemElectromed, 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.

↑