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510(k) Data Aggregation
K Number
K962749Device Name
THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT
Manufacturer
DIEMOLDING CORP.
Date Cleared
1996-10-10
(87 days)
Product Code
BWF
Regulation Number
868.5690Why did this record match?
Applicant Name (Manufacturer) :
DIEMOLDING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DHD TheraPEP is intended for use as a Positive Expiratory Pressure Device for patients suffering from Cystic Fibrosis, lung diseases with secretory problems, and to prevent or reverse atelectasis.
Device Description
The DHD TheraPEP is a single-patient-use Respiratory Therapy device. The standard system consists of a resistor, pressure range indicator, pressure port adapter, and mouthpiece. The mask may be substituted for the mouthpiece. Pressure monitoring is optional, and the pressure port adapter is removable.
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K Number
K961455Device Name
MEDSHIELD/AEROCHAMBER
Manufacturer
DIEMOLDING CORP.
Date Cleared
1996-07-25
(100 days)
Product Code
CCQ
Regulation Number
868.5640Why did this record match?
Applicant Name (Manufacturer) :
DIEMOLDING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DHD MedShield is a single-patient-use device. The Intended Use of the device is to reduce the taste effect of Metered Dose Inhaler (MDI) drugs by covering the tongue in the taste sensor area.
Device Description
The MedShield product reduces drug deposition in the tongue when used in conjunction with metered dose inhaler (MDI) medications. The device attaches to an MDI elbow and shields the tongue of the user from the medication spray. Drug that deposits on the device would otherwise be on the users tongue. Based on this, the taste effect of the medications is reduced. This simple device includes two different features. 1. The patient end of the device covers the tongue. The patient end may vary to maximize the comfort of a wide range of users. 2. The elbow end of the device includes a universal clip, which attaches the device to all MDI elbows. To satisfy the preferences of various customers, the force required to separate (or attach) the device to various elbows can be modified by adjusting the clip or modifying the taper around the clip. The MedShield product has been designed to conform with ASTM F963-92, "Standard Consumer Safety Specification on Toy Safety, under Section 4.6, Small Objects, specifically 4.6.2, Mouth-Actuated Toys, and CFR 16-1511.1, "Requirements For Pacifically, 1511.5 Structural integrity tests for Small Parts, 1511.5 (d), to ensure that the device does not present a choke hazard. The MedShield is designed for single patient use. Patients may be given the product for use either in a hospital or home environment for extended time periods. Recommendations for cleaning, in cases of extended time, are included in the instructions for use.
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