Unitron Industries, Inc.

United StatesFDA 510(k) applicant, unverified

Devices: 69

What Unitron Industries, Inc. makes

Unitron Industries, Inc. manufactures air conduction hearing aids, including customizable models like the UM60 series (UM60-D, UM60-H, UM60-PP) and programmable in-the-ear devices such as the Sound F/X II and Sound F/X Programmable ITE. Additional offerings include the E1-PL and E1-P models, as well as specialized variants like the IKON PP and the VISTA 1000 SIGMA.

These devices are classified under Class I in the US and are listed via the FDA’s 510(k) pathway. The company is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue69

Newest first, rows 51-69 of 69

Search and filter all 69 devices

Unitron Model Sound F/Xp Ref K960155

Class I

Active 510(k) 510(k) I
Hearing Aid, Unitron Models UE3/3-N Ref K821899

Class I

Active 510(k) 510(k) I
Hearing Aid, Unitron Model UE7 Ref K822805

Class I

Active 510(k) 510(k) I
Hearing Aid Ue-10-H Ref K823366

Class I

Active 510(k) 510(k) I
Unitron Model Esteem Ref K950759

Class I

Active 510(k) 510(k) I
Hearing Aid, Unitron UE3-D/Dn Ref K822506

Class I

Active 510(k) 510(k) I
Hearing Aid, Unitron Model UE5 Ref K821900

Class I

Active 510(k) 510(k) I
Unitron Model Icon Kr Ref K963122

Class I

Active 510(k) 510(k) I
Hearing Aid, Unitron UT1 Ref K833614

Class I

Active 510(k) 510(k) I
Unitron Model Icon Aohp +4 (Icon Aohp +4) Ref K964508

Class I

Active 510(k) 510(k) I
Hearing Aid, Unitron Model Vista 1000 Ref K883513

Class I

Active 510(k) 510(k) I
Hearing Aid Model UE9-R Ref K813229

Class I

Active 510(k) 510(k) I
Hearing Aid, Unitron Model 975 Ref K781434

Class I

Active 510(k) 510(k) I
Unitron Model Icon Aohpd +4 (Icon Aohpd +4) Ref K964510

Class I

Active 510(k) 510(k) I
Unitron Model Sound F/Xp +4 Ref K964502

Class I

Active 510(k) 510(k) I
Hearing Aid, Unitron Model UM60-Uh Ref K904576

Class I

Active 510(k) 510(k) I
Hearing Aid, Unitron Model UI5 Ref K882375

Class I

Active 510(k) 510(k) I
Hearing Aid, Unitron Model C4-55 Ref K801230

Class I

Active 510(k) 510(k) I
Hearing Aid Unitron #UE8-D Ref K831883

Class I

Active 510(k) 510(k) I

Rows 51-69 of 69

Showing 51-69 of 69

What Unitron Industries, Inc. makes

Catalogue69

Unitron Model Sound F/Xp Ref K960155

Hearing Aid, Unitron Models UE3/3-N Ref K821899

Hearing Aid, Unitron Model UE7 Ref K822805

Hearing Aid Ue-10-H Ref K823366

Unitron Model Esteem Ref K950759

Hearing Aid, Unitron UE3-D/Dn Ref K822506

Hearing Aid, Unitron Model UE5 Ref K821900

Unitron Model Icon Kr Ref K963122

Hearing Aid, Unitron UT1 Ref K833614

Unitron Model Icon Aohp +4 (Icon Aohp +4) Ref K964508

Hearing Aid, Unitron Model Vista 1000 Ref K883513

Hearing Aid Model UE9-R Ref K813229

Hearing Aid, Unitron Model 975 Ref K781434

Unitron Model Icon Aohpd +4 (Icon Aohpd +4) Ref K964510

Unitron Model Sound F/Xp +4 Ref K964502

Hearing Aid, Unitron Model UM60-Uh Ref K904576

Hearing Aid, Unitron Model UI5 Ref K882375

Hearing Aid, Unitron Model C4-55 Ref K801230

Hearing Aid Unitron #UE8-D Ref K831883