Electone, Inc.
United StatesFDA applicant, unverified
- Devices
- 73
What Electone, Inc. makes
Electone, Inc. manufactures a range of hearing aids, including rechargeable and in-the-ear models such as the Z33, EAGLE I, AM 31, and M30. The company also produces personal amplifier devices, including the PREMIER CD RECHARGEABLE, PERSONAL AMPLIFIER MODULE, and ULTRA HELIX. Additional offerings include the AM 260 K-AMP, PREMIER CLASS D-ASP, and the SONATA U-01, along with programming modules like the MODULE PROGRAM.
Electone’s devices are classified under FDA categories Class I and Class II, with several listed via the 510(k) pathway. The company is based in the United States, and its products are registered under U.S. regulatory frameworks.
Catalogue
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