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)

THERAPEP

K-Number: K983467 · 1999-04-02

ApplicantDhd Healthcare Corp.
Decision Date1999-04-02
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THERAPEP is the device name listed in this FDA 510(k) record. The listed applicant is Dhd Healthcare Corp.. It received FDA 510(k) clearance on 1999-04-02 under 510(k) number K983467. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERAPEP?

THERAPEP is a medical device that received FDA 510(k) clearance on 1999-04-02. The listed applicant is Dhd Healthcare Corp.. The 510(k) number is K983467.

When did THERAPEP receive FDA 510(k) clearance?

THERAPEP received FDA 510(k) clearance on 1999-04-02, under 510(k) number K983467.

Who is the listed applicant for THERAPEP?

The FDA 510(k) record lists Dhd Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERAPEP?

The FDA product code for THERAPEP is BWF.

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 Dhd Healthcare Corp. 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.

K040718TRUSTK002768ACAPELLAK003146CLINIFLO INCENTIVE SPIROMETERK991561ROADRUNNER, PEP THERAPY DEVICEK991300BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICEK980662LICHEN, BACTERIAL IN LINE BREATHING FILTER

View all 8 devices →

Related Devices (Code: BWF)

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.

K241152InSeeTidal Medical Technologies, LLCK233855AllPEPEnchant Tek Co. , Ltd.K221058LungTrainer (MD2 & MD3)Lung Trainers, LLCK222018Breathe+Peep Medical, LLC Dba Go2 DevicesK220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserMedline Industries, Inc.K203378PulsehalerRespinova, Ltd.

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.

↑