FDA Registration
Active
🇺🇸 United States
PLSB
Reg #: 1000560772
·
FEI: 1000560772
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BIOSCULPTOR CORPORATION
- Registration Number
- 1000560772
- FEI Number
- 1000560772
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2480 W 82nd St Unit 1
- City
- Hialeah
- State
- FL
- ZIP
- 33016
- Country
- US
Owner / Operator
- Firm Name
- BioSculptor Corporation
- Operator Number
- 10028416
- Address
- 2480 West 82nd Street, #1, Bay 1A
- City
- Hialeah
- State
- FL
- Postal Code
- 33016
- Country
- US
- Correspondent
- Mark J Mazloff
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2015-01-05 |
Proprietary Names
PLSB
PLS-FF, PLS-FF-OH
PLSC, PLSC-OH
Maramed Orthopedic System
PLS-S, PLS-S-OH
Miami Fracture Brace
Maramed
Sky Medical Ankle Foot Orthosis, AFO
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device