INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE
Device Facts
| Record ID | K945287 |
|---|---|
| Device Name | INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE |
| Applicant | Helix Medical, Inc. |
| Product Code | EWL · Ear, Nose, Throat |
| Decision Date | Dec 9, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3730 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A laryngeal prosthesis (Taub design) is a device intended to direct pulmonary air flow to the pharynx in the absence of the larynx, thereby permitting esophageal speech. The device is interposed between openings in the trachea and the esophagus and may be removed and replaced each day by the patient. During phonation, air from the lungs is directed to flow through the device and over the esophageal mucosa to provide a sound source that is articulated as speech.
Special Controls
*Classification.* Class II (special controls). The device, when it is a voice amplification device, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
