FDA Registration
Active
🇺🇸 United States
Micro-Z Mini
Reg #: 1055808
·
FEI: 1000110974
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- PRIZM MEDICAL, INC.
- Registration Number
- 1055808
- FEI Number
- 1000110974
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 940 Sherwin Pkwy, Suite 100
- City
- Buford
- State
- GA
- ZIP
- 30518
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133502
Owner / Operator
- Firm Name
- PRIZM MEDICAL, INC.
- Operator Number
- 9005746
- Address
- 940 Serwin Parkway, Suite 100
- City
- Buford
- State
- GA
- Postal Code
- 30518
- Country
- US
- Correspondent
- Jim Johnson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2014-12-30 |
Proprietary Names
Micro-Z Mini
Living Well with Montel
ReviStim
AMS 200
MicroTENS II
TruMedic
Sport-Z
Micro-Z II
Micro-Z nano
SaeboStim Micro
Establishment Types
Reprocess Single-Use Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device