FDA Registration
Active
🇺🇸 United States
Ultra
Reg #: 2523532
·
FEI: 2523532
·
Expires 2025
Products
1
Proprietary Names
34
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- Hearing Lab Technology, LLC.
- Registration Number
- 2523532
- FEI Number
- 2523532
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 806 Beaver St
- City
- West Bristol
- State
- PA
- ZIP
- 19007
- Country
- US
Owner / Operator
- Firm Name
- Hearing Lab Technology, LLC
- Operator Number
- 2523532
- Address
- 806 BEAVER ST., --
- City
- West Bristol
- State
- PA
- Postal Code
- 19007
- Country
- US
- Correspondent
- SUSAN - REID
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2014-06-02 |
Proprietary Names
Ultra
RITE96WL
Freedom
Accent
Liberty
Ear Back Hearing Aid RITEWL48 2360
Elevate
Aspire
America Hears
Ear Back Hearing Aid RITEWL96 4360
Member's Selection U128
Member's Selection A128
Member's Selection U24
Present
Member's Selection U48
Member's Selection A48
Member's Selection A24
Member's Selection A48 Model # 2465
Member's Selection A128 Model # 5465
Ear Back Hearing Aid Models 756
Member's Selection U48 Model # 2565
Member's Selection U24 Model # 7565
Ear Back Hearing Aid Models 446
Ear Back Hearing Aid Models 556
Ear Back Hearing Aid Models 557
Member's Selection U128 Model # 5575
Ear Back Hearing Aid Models 546
Lucid
Ear Back Hearing Aid Models 246
Ear Back Hearing Aid Models 256
Member's Selection A24 Model # 7465
Universal
Ear Back Hearing Aid Models 746
Ear Back Hearing Aid Models 456
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device