FDA Registration
Active
🇺🇸 United States
NATRACURE PLANTAR FASCITIS NIGHT SPLINT (W/GEL
Reg #: 3005621376
·
FEI: 3005621376
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- POLYGEL LLC.
- Registration Number
- 3005621376
- FEI Number
- 3005621376
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1 Danforth Drive
- City
- Palmer TWP
- State
- PA
- ZIP
- 18045
- Country
- US
Owner / Operator
- Firm Name
- POLYGEL LLC.
- Operator Number
- 9080190
- Address
- 1 Danforth Dr., --
- City
- Palmer
- State
- PA
- Postal Code
- 18045
- Country
- US
- Correspondent
- LAWRENCE - KERSEN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2005-12-05 |
Proprietary Names
NATRACURE PLANTAR FASCITIS NIGHT SPLINT (W/GEL
THERMOACTIVE MEDICAL SHOULDER ORTHOSIS
NATRACURE ARTHRITIS COMPRESSION GLOVES (615-02 CAT/615-03 CAT/615-04 CAT)
NATRACURE KNEE COMPRESSION SLEEVE, SINGLE WRAP (605-02 CAT/605-03 CAT/605-04 CAT/605-05 CAT/
NIGHT-TIME BUNION SPLINT
THERMOACTIVE BACK SUPPORT WITH SUPPORTS (LSO)
THERMOACTIVE KNEE ORTHOSIS WITH ROM HINGES
NATRACURE NEOPRENE MAGNETIC SHOULDER SUPPORT
THERMOACTIVE KNEE ORTHOSIS WITH POLYCENTRIC HINGES
SGEL BAMBOO KNEE SLEEVE
THERMOACTIVE MEDICAL HIP ORTHOSIS
THERMOACTIVE ELBOW ORTHOSIS SUPPORT WITH POLYCENTRIC HINGES
THERMOACTIVE ELBOW ORTHOSIS SUPPORT WITH ROM HINGES
THERMOACTIVE WRIST SYSTEM ORHTOSIS WITH SPLINT
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility