iCH CPAP with PVA 9S-007XXX Series
by Apex Medical Corp. 2 variants
510(k) K150111
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150111 | Date15 Sep 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
- 510(k) Number
- FDA Product Code
- BZD
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5905
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The iCH CPAP with PVA 9S-007XXX Series is a Non-Continuous Ventilator (Respirator) designed to deliver continuous positive airway pressure (CPAP) or auto-titrating positive airway pressure (APAP) for the treatment of obstructive sleep apnea (OSA) in adults. It pressurizes ambient air via an internal blower and delivers it to the patient through a mask, ensuring sustained airway patency during sleep. The device incorporates a built-in heated humidifier to reduce dryness in the nasal and throat passages, enhancing patient comfort. Its adaptive pressure algorithms adjust ventilation parameters in response to detected apneas, automatically suspending and restarting therapy as needed.
This device is intended for use in clinical and home settings by healthcare providers and patients, respectively. It is supplied as a reusable medical device, requiring periodic maintenance and cleaning as specified by the manufacturer. The iCH CPAP with PVA 9S-007XXX Series has received FDA 510(k) clearance under the Anesthesiology advisory committee, classified as a Class II device (Regulation Number: 868.5905). It operates in both CPAP and APAP modes, with settings configurable by healthcare providers for therapeutic titration. The device is not MRI-compatible and must be stored in a clean, dry environment, protected from physical damage and contamination.
Other devices from Apex Medical Corp.
Questions
AI-generated answers, 20 Sep 2026
What clinical settings and by whom is the Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series intended for use?
The iCH CPAP with PVA 9S-007XXX Series is designed for use in both clinical and home settings. In clinical environments, it is intended for use by healthcare providers, while in home settings, it is intended for use by patients themselves for the treatment of obstructive sleep apnea (OSA).
Is the Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series a single-use or reusable device, and what maintenance is required?
The iCH CPAP with PVA 9S-007XXX Series is a reusable medical device. It requires periodic maintenance and cleaning as specified by the manufacturer to ensure proper functionality and hygiene, particularly since it is used in both clinical and home settings.
What storage conditions are recommended for the Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series?
The device must be stored in a clean, dry environment, protected from physical damage and contamination. It is also important to note that the iCH CPAP is not MRI-compatible, so it should be kept away from MRI machines to prevent potential interference or damage.
Does the Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series have features to enhance patient comfort during use?
Yes, the iCH CPAP with PVA 9S-007XXX Series includes a built-in heated humidifier to reduce dryness in the nasal and throat passages, which significantly enhances patient comfort during therapy. This feature is particularly beneficial for those experiencing dryness or irritation from continuous airflow.
What modes of operation does the Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series support, and how are its settings configured?
The iCH CPAP with PVA 9S-007XXX Series operates in both CPAP (Continuous Positive Airway Pressure) and APAP (Auto-Titrating Positive Airway Pressure) modes. The settings for these modes are configurable by healthcare providers, allowing for therapeutic titration tailored to individual patient needs, particularly for managing obstructive sleep apnea.