FDA Registration
Active
🇺🇸 United States
FKA Distributing Co., LLC
Reg #: 1832894
·
FEI: 1832894
·
Expires 2026
Products
20
Proprietary Names
5
Establishment Types
2
Classifications
20
Registration Details
- Registration Name
- FKA Distributing Co., LLC
- Registration Number
- 1832894
- FEI Number
- 1832894
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3000 N Pontiac Trl
- City
- Commerce Township
- State
- MI
- ZIP
- 48390
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171888
Owner / Operator
- Firm Name
- FKA Brands
- Operator Number
- 1832894
- Address
- 3000 N Pontiac Trail, --
- City
- Commerce Twp
- State
- MI
- Postal Code
- 48390
- Country
- US
- Correspondent
- Laura - Foos
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-03-27 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-04-03 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2004-03-08 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2019-12-30 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-11-15 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2020-09-14 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2020-01-16 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2020-01-16 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2023-09-29 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2023-09-29 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2023-09-29 |
| Cold Pack And Vibrating Massager | PHW | Class 1 | Physical Medicine | No | 2017-03-30 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2023-09-29 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2014-01-07 |
| Semen Analysis Device | POV | Class 2 | Hematology | No | 2019-12-18 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2006-12-14 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2006-12-14 |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | Class 2 | Neurology | No | 2020-01-16 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2022-11-15 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2022-11-15 |
Proprietary Names
HoMedics
ObusForme
7LS
HoMedics Bubble Bliss Elite Footbath
Homedics
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device