FDA Registration
Active
🇺🇸 United States
MICRO-Z II
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
- K033122
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 | 2006-01-12 |
Proprietary Names
MICRO-Z II
SPORT-Z
MICRO-Z MINI
MICRO-Z NANO
MicroTENS II
TruMedic
ReviStim
AMS 200
Living Well with Montel
SaeboStim Micro
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device