FDA Registration
Active
🇺🇸 United States
POSTERIOR LEAF SPLINT
Reg #: 2128677
·
FEI: 2128677
·
Expires 2025
Products
1
Proprietary Names
22
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PERFORMANCE HEALTH SUPPLY, LLC.
- Registration Number
- 2128677
- FEI Number
- 2128677
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- W68 N158 EVERGREEN BLVD.
- City
- CEDARBURG
- State
- WI
- ZIP
- 53012
- Country
- US
Owner / Operator
- Firm Name
- Performance Health Supply
- Operator Number
- 10050734
- Address
- 3333 Finley Road, Suite 575
- City
- Downers Grove
- State
- IL
- Postal Code
- 60515
- Country
- US
- Correspondent
- Paul Hanneman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2015-12-22 |
Proprietary Names
POSTERIOR LEAF SPLINT
ROLYAN WEDGE FLEX
Rolyan Aquaplast-T
Rolyan AquaForm (all types)
Rolyan Polyflex II
Semi-Compressed Mixed Felt *9
ROLYAN ANKLE FOOT ORTHOSIS
ROLYAN STRAPS - ALL CONFIGURATIONS & ACCESSORIES
ROLYAN POST SURGICAL ARM SUPPORT
Rolyan Synergy
Rolyan Aquaplast Prodrape-T
Rolyan CuraDrape
Rolyan Ezeform
Rolyan Polyform
Rolyan Aquaplast Original
PADDING - ALL THICKNESSES & CONFIGURATIONS
Rolyan Aquaplast Resilient-T
Rolyan Tailorsplint
Rolyan Aquaplast Watercolors
ROLYAN DYNAMIC PRONATION/SUPINATION KIT
Rolyan Aquaplast Original Resilient
ROLYAN INCREMENTAL WRIST HINGE
Establishment Types
Manufacture Medical Device