FDA Registration Active 🇺🇸 United States

MICROSONIC, INC.

Reg #: 2523819 · FEI: 2523819 · Expires 2026
Products
2
Proprietary Names
24
Establishment Types
4
Classifications
2

Registration Details

Registration Name
MICROSONIC, INC.
Registration Number
2523819
FEI Number
2523819
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
2960 DUSS AVE.
City
AMBRIDGE
State
PA
ZIP
15003
Country
US

Regulatory Submissions

510(k) Number
K950912

Owner / Operator

Firm Name
Microsonic, Inc.
Operator Number
2523819
Address
2960 Duss Ave.
City
Ambridge
State
PA
Postal Code
15003
Country
US

Products

Device Name Product Code
Hearing Aid, Air-Conduction, Prescription ESD
Protector, Hearing (Insert) EWD

Proprietary Names

#12 Standard Tube, #13 Medium Tube, #13 Thick Tube, #13 Double Wall Tube Acrylic with Vinylflex Canal, Acrylic with Synth-A-Flex Canal Tube Lock, Tube Lock Plus, Gold Lock, Silver Lock, Invisilock Open Fit Earmold, Slim Fit Earmold, Polyethylene Earmold, PassGuard Earmold MikroLok Medi-Sil, Super Alerite, Acrylic Earmold Addition Supra Plus Swim Plug, Neon Lite, Micro Canal, Microshell M2000, M2000 Plus, Synth-A-Flex, Vinylflex Single Bend, Solo Bend, Double Bend Dri-Tube Moisture-Free Tubes, Vibrant Color Tube, Gold Lock DW, Alerite Body with Silicone Canal M2000 Neon Lites LifePlugs Sound Defenders PassGuard Musicians Earplugs ER Plugs SoftGuard AgileEars Swim Plugs Mega-Sil Silasoft

Establishment Types

Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility