Larynx, Artificial (Battery-Powered)
The battery-powered artificial larynx is an electrolaryngeal device held against the throat or placed intraorally that generates sound vibrations for individuals who have lost their natural voice due to laryngectomy or other conditions. It is classified as FDA Class 1, indicating the lowest risk, subject only to general controls. The product code is ESE, regulated under 21 CFR 874.3375 in the Ear, Nose, Throat specialty. No special regulatory flags apply.
Basic Information
- Product Code
- ESE
- Device Class
- FDA class 1
- Regulation Number
- 874.3375
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934483 | NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX | Mar 16, 1994 | Substantially Equivalent | Mountain Precision Mfg. Ltd. Co. |
| K931371 | DENRICK SPEECH AID (DR-1) | Aug 25, 1993 | Substantially Equivalent | Denrick Corp. |
| K923648 | LECTRO-LARYNX | Apr 07, 1993 | Substantially Equivalent | Bruce Medical Supply |
| K914816 | AMERICAN ARTIFICIAL LARYNX | Feb 12, 1993 | Substantially Equivalent | Ultravoice, Ltd. |
| K901503 | ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM | Jun 28, 1990 | Substantially Equivalent | Stanton Magnetics, Inc. |
| K860992 | VOX COMPANION | May 02, 1986 | Substantially Equivalent | Bloomfield Research and Development, Inc. |
| K860993 | P.O. VOX | Apr 25, 1986 | Substantially Equivalent | Bloomfield Research and Development, Inc. |
| K854158 | RESNICK EMITTER, ARTIFICIAL LARYNX | Dec 13, 1985 | Substantially Equivalent | Dynamed Audio, Inc. |
| K840892 | ELECTRO-PALATE | May 22, 1984 | Substantially Equivalent | Cisko Systems |
| K834555 | BEAR VENTI--VOICE | Jan 24, 1984 | Substantially Equivalent | Bear Medical Systems, Inc. |
| K834522 | VENTI-VOICE NASAL CATHETER | Jan 17, 1984 | Substantially Equivalent | Respiratory Support Products, Inc. |
| K831127 | INTRA-ORAL ARTIFICIAL LARYNX | Jul 28, 1983 | Substantially Equivalent | Xomed, Inc. |
| K823118 | SAY | Jan 07, 1983 | Substantially Equivalent | Kells Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.