Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1527181

FEI Number

1527181

Entity Name

POLYMER CONCEPTS, INC.

City/State/Country

Mentor, OH, US

Establishment Address

7555 TYLER BLVD STE 1, Mentor, OH 44060, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Polymer Concepts Inc (Owner Number: 1527181)

Owner / Operator Contact Address

7555 TYLER BLVD., Suite 1, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

XcelGel HeelPleezr

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2001-12-20
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2001-04-09

Official Correspondent

Amy Imperatore

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Polymer Concepts Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1527181. Last updated year: 2026. Please use registration number 1527181 when referencing this establishment in official correspondence.