← Product Code [BWF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF) · K962749 # THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT (K962749) _Diemolding Corp. · BWF · Oct 10, 1996 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K962749 ## Device Facts - **Applicant:** Diemolding Corp. - **Product Code:** [BWF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF.md) - **Decision Date:** Oct 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5690 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Indications for 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 Story TheraPEP is a single-patient-use respiratory therapy device; consists of resistor, pressure range indicator, pressure port adapter, and mouthpiece or mask. Operates by providing positive expiratory pressure to patient airways. Used in clinical or home settings to assist in airway clearance and lung expansion. Healthcare provider or patient uses device to facilitate secretion removal and prevent/reverse atelectasis. Output is controlled expiratory resistance; optional pressure monitoring via port adapter allows tracking of therapy performance. ## Clinical Evidence No new clinical testing performed. Evidence relies on reference documents/literature supporting the efficacy of PEP therapy for the prevention and reversal of atelectasis. ## Technological Characteristics Single-patient-use respiratory device; includes resistor, pressure range indicator, pressure port adapter, and mouthpiece/mask interface. Mechanical operation; no energy source required. ISO 9001 certified manufacturing. ## Regulatory Identification An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation. ## Predicate Devices - DHD TheraPEP ([K962749](/device/K962749.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K962749 DHD DIEMOLDING HEALTHCARE DIVISION Corporate Offices: 125 Rasbach Street Canastota, NY 13032 USA (315) 697-2221 (800) 847-8000 (315) 697-8083 FAX Manufacturing and Distribution Facilities: One Madison Street Wampsville, NY 13163 USA (315) 363-2330 (315) 363-9462 FAX OCT 10 1996 # 510(k) SUMMARY As Required by 807.92(c) 7-11-96 1. Submitter: DHD Diemolding Healthcare Division 125 Rasbach Street Canastota, NY 13032 Phone: 315-697-2221 Fax: 315-697-8083 Contact: Jean Wallace, Manager, Regulatory Affairs 2. Device Name - Trade Name - TheraPEP® - Common name - Positive Expiratory Pressure (PEP) device - Classification name - Incentive Spirometer - 868.5690 3. Predicate Device: DHD TheraPEP (addition to claims only). 4. 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. 5. 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. (Note that added claims are indicated in italics.) 6. Technological Information No technological changes - submission is only to add claim. 7. Summary of Studies The clinical data (reference documents) supporting the added claims show that PEP therapy is effective for prevention and reversal of atelectasis. 8. Conclusions Drawn from Studies The added indication (to prevent or reverse atelectasis) for PEP therapy will not adversely affect the safety and effectiveness of the TheraPEP device when utilized for this application as TheraPEP is approved for PEP therapy. ISO CERTIFIED 9001 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K962749](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K962749) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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