ESE · Larynx, Artificial (Battery-Powered)
Ear, Nose, Throat · 21 CFR 874.3375 · Class 1
Overview
| Product Code | ESE |
|---|---|
| Device Name | Larynx, Artificial (Battery-Powered) |
| Regulation | 21 CFR 874.3375 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
Identification
A battery-powered artificial larynx is an externally applied device intended for use in the absence of the larynx to produce sound. When held against the skin in the area of the voicebox, the device generates mechanical vibrations which resonate in the oral and nasal cavities and can be modulated by the tongue and lips in a normal manner, thereby allowing the production of speech.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934483 | NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX | Mountain Precision Mfg. Ltd. Co. | Mar 16, 1994 | SESE |
| K931371 | DENRICK SPEECH AID (DR-1) | Denrick Corp. | Aug 25, 1993 | SESE |
| K923648 | LECTRO-LARYNX | Bruce Medical Supply | Apr 7, 1993 | SESE |
| K914816 | AMERICAN ARTIFICIAL LARYNX | Ultravoice, Ltd. | Feb 12, 1993 | SESE |
| K901503 | ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM | Stanton Magnetics, Inc. | Jun 28, 1990 | SESE |
| K860992 | VOX COMPANION | Bloomfield Research and Development, Inc. | May 2, 1986 | SESE |
| K860993 | P.O. VOX | Bloomfield Research and Development, Inc. | Apr 25, 1986 | SESE |
| K854158 | RESNICK EMITTER, ARTIFICIAL LARYNX | Dynamed Audio, Inc. | Dec 13, 1985 | SESE |
| K840892 | ELECTRO-PALATE | Cisko Systems | May 22, 1984 | SESE |
| K834555 | BEAR VENTI--VOICE | Bear Medical Systems, Inc. | Jan 24, 1984 | SESE |
| K834522 | VENTI-VOICE NASAL CATHETER | Respiratory Support Products, Inc. | Jan 17, 1984 | SESE |
| K831127 | INTRA-ORAL ARTIFICIAL LARYNX | Xomed, Inc. | Jul 28, 1983 | SESE |
| K823118 | SAY | Kells Medical, Inc. | Jan 7, 1983 | SESE |
Top Applicants
- Bloomfield Research and Development, Inc. — 2 clearances
- Bear Medical Systems, Inc. — 1 clearance
- Bruce Medical Supply — 1 clearance
- Cisko Systems — 1 clearance
- Denrick Corp. — 1 clearance
