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Sign in to claim this brandProfessional Products, Inc.
United States·US-MF-000019828
Last updated September 17, 2026
About
Ezy Wrap develops and delivers innovative high-value orthopedic supports and braces. Our products enable favorable patient outcomes from preventative bracing through post-operative recovery and set the standards for quality, comfort, durability, and integrated cold therapy
From the manufacturer's own website. Source
What Professional Products, Inc. makes
Professional Products, Inc. manufactures ankle/foot orthoses, including platform hand orthoses, cervical collars, and shoulder immobilizers like the Vest Shoulder Immobilizer. Their portfolio also includes cold therapy products such as Cold Therapy Bags and First Gel Direct Stick Packs, as well as compression garments like MARLENE Stockings & Tights. Additional offerings include the Tennis Elbow Support System and the Manuconfort PM.
The company’s devices are classified as Class I or Class II and are listed in the EUDAMED registry and the FDA’s 510(k) database. Professional Products, Inc. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Professional Products, Inc. primarily manufacture?
Professional Products, Inc. specializes in ankle and foot orthoses, including devices like the Platform Hand Orthosis and Cervical Collar. Their portfolio also covers shoulder immobilizers (e.g., Vest Shoulder Immobilizer), cold therapy solutions (Cold Therapy Bags, First Gel Direct Stick Packs), compression garments (MARLENE Stockings & Tights), and specialized supports like the Tennis Elbow Support System and Manuconfort PM. These products span preventative, rehabilitative, and post-operative care.
Where is Professional Products, Inc. based, and how does that affect its regulatory standing?
Professional Products, Inc. is headquartered in the United States. This means its devices are subject to U.S. FDA regulations, including pre-market notifications like the 510(k) process for Class II devices, while Class I products may require general controls or exemptions. Internationally, their devices are also listed in the EUDAMED registry, indicating compliance with EU Medical Device Regulations (MDR) or previous directives.
Which regulatory registries list devices manufactured by Professional Products, Inc., and why?
Devices from Professional Products, Inc. appear in the EUDAMED registry (for EU market access) and the FDA’s 510(k) database (for U.S. Class II devices). EUDAMED ensures traceability under EU Medical Device Regulations, while the FDA’s 510(k) database confirms U.S. compliance for higher-risk Class II devices, demonstrating their regulatory pathways in both markets.
How are Professional Products, Inc.’s devices classified under medical device regulations?
Professional Products, Inc.’s devices fall into Class I (lower-risk, often exempt from premarket review) or Class II (moderate-risk, requiring specific controls like the FDA’s 510(k) process or EU conformity assessments). Classification depends on factors like intended use (e.g., cold therapy bags are typically Class I, while shoulder immobilizers may be Class II due to structural or functional risks).
Why might a clinician or patient look up Professional Products, Inc. in regulatory databases?
Clinicians or patients may verify a device’s regulatory status in databases like EUDAMED or the FDA’s 510(k) listings to confirm compliance, intended use, and manufacturer details. For example, a Vest Shoulder Immobilizer (Class II) would require validation of its FDA clearance or EU conformity, ensuring safety and efficacy for post-operative or injury management. These registries also help identify recalls or design changes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 54 Hugh Adams Rd, Defuniak Springs, FL, United States
- Website
- www.ezywrap.com/
- —
- facebook.com/EzyWrapPPI
- [email protected]
- Phone
- +1 850-892-5731
- PRRC Contact
- Trenton Kilbey
- EUDAMED SRN
- US-MF-000019828
- FDA FEI Number
- 1026765
- DUNS Number
- —
Catalogue (333)
Page 1 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mollosil Plus Adhesion Promoter | FIXX3 | FDA UDI | Class II | Active |
| ProTech Plus Hard Reline and Repair Acrylic | PLU12GD | FDA UDI | Class II | Unknown |
| ProTech UBAR | UBAR65D | FDA UDI | Class II | Active |
| ProTech SuperBond | SRSB | FDA UDI | Class II | Unknown |
| ProTech Plus Tooth Acrylic | RUCOWOA1 | FDA UDI | Class II | Unknown |
| ProTech UBAR | UBARV11AD | FDA UDI | Class II | Active |
| ProTech Plus Hard Reline and Repair Acrylic | PLU14F | FDA UDI | Class II | Unknown |
| Permafix | FIX2 | FDA UDI | Class II | Unknown |
| ProTech Soft Reline | SRHP2C | FDA UDI | Class II | Unknown |
| ProTech Soft Reline | SRCP5C | FDA UDI | Class II | Unknown |
| ProTech Soft Reline | SRHP2PV | FDA UDI | Class II | Unknown |
| ProTech Plus Hard Reline and Repair Acrylic | PLUS12GD | FDA UDI | Class II | Active |
| ProTech UBAR | UBARV11A | FDA UDI | Class II | Active |
| ProTech Plus Tooth Acrylic | RUC67LB | FDA UDI | Class II | Unknown |
| ProTech Plus Tooth Acrylic | RUCOW | FDA UDI | Class II | Unknown |
| ProTech SuperBond | SBL11 | FDA UDI | Class II | Unknown |
| ProTech UBAR | UBAR11A | FDA UDI | Class II | Active |
| ProTech Plus Tooth Acrylic | RUC59A1 | FDA UDI | Class II | Unknown |
| ProTech UBAR | UBAR81D | FDA UDI | Class II | Active |
| ProTech UBAR | UBAR65B | FDA UDI | Class II | Active |
| ProTech UBAR | UBARV11GA | FDA UDI | Class II | Active |
| ProTech UBAR | UBAR62 | FDA UDI | Class II | Active |
| ProTech Soft Reline | LRC11 | FDA UDI | Class II | Unknown |
| ProTech Plus Tooth Acrylic | RUCPO | FDA UDI | Class II | Unknown |
| ProTech Plus Hard Reline and Repair Acrylic | PLU13G | FDA UDI | Class II | Unknown |
| ProTech UBAR | UBAR59B | FDA UDI | Class II | Active |
| Mollosil Plus Glaze and Catalyst | FIXX4 | FDA UDI | Class II | Active |
| ProTech Plus Tooth Acrylic | RUC66A1 | FDA UDI | Class II | Unknown |
| ProTech UBAR | UBAR11GA | FDA UDI | Class II | Active |
| ProTech Soft Reline | SRH11PV | FDA UDI | Class II | Unknown |
| ProTech Plus Tooth Acrylic | RUC62A1 | FDA UDI | Class II | Unknown |
| ProTech Plus Tooth Acrylic | RUC87A1 | FDA UDI | Class II | Unknown |
| ProTech UBAR | UBAR62D | FDA UDI | Class II | Active |
| ProTech Plus Tooth Acrylic | RUC66LB | FDA UDI | Class II | Unknown |
| ProTech Soft Reline | SRC12PV | FDA UDI | Class II | Unknown |
| ProTech Plus Tooth Acrylic | RUCDIA | FDA UDI | Class II | Unknown |
| ProTech Plus Tooth Acrylic | RUC66 | FDA UDI | Class II | Unknown |
| ProTech Plus Tooth Acrylic | RUC65 | FDA UDI | Class II | Unknown |
| ProTech Soft Reline | SRC13C | FDA UDI | Class II | Unknown |
| ProTech Soft Reline | SRCP5PV | FDA UDI | Class II | Unknown |
| ProTech UBAR | UBAR65 | FDA UDI | Class II | Active |
| ProTech UBAR | RUCV11AD | FDA UDI | Class II | Unknown |
| ProTech Plus Hard Reline and Repair Acrylic | PLU15F | FDA UDI | Class II | Unknown |
| ProTech Soft Reline | SRHP1PV | FDA UDI | Class II | Unknown |
| ProTech Soft Reline | SRH13PV | FDA UDI | Class II | Unknown |
| PermaLiner | SILL1 | FDA UDI | Class II | Active |
| ProTech Plus Tooth Acrylic | RUC77A | FDA UDI | Class II | Unknown |
| ProTech UBAR | RUCV11GC | FDA UDI | Class II | Unknown |
| ProTech Soft Reline | SRC12C | FDA UDI | Class II | Unknown |
| ProTech Plus Tooth Acrylic | RUC87LB | FDA UDI | Class II | Unknown |
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