Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2431499

FEI Number

3009710062

Entity Name

PEDIFIX, INC.

City/State/Country

BREWSTER, NY, US

Establishment Address

301 FIELDS LN, BREWSTER, NY 10509, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

PEDIFIX, INC. (Owner Number: 2431499)

Owner / Operator Contact Address

301 FIELDS LN, --, Brewster, NY 10509, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Visco-Gel VISCO-GEL Bunion Shield (L/R) Toe Cap (S,M,L) Visco-Gel Toe Budin Toe Splint CVS Bunion Soft Splint SoreSpot SILICONE TAPE Hallux Splint (SL,SR,ML,MR,LL,LR) Arch Bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2015-12-17
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2014-09-15
IQM	Splint, Temporary Training	Physical Medicine	Class 1	890.3025	1978-07-20
HXT	Tape, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2020-05-14
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2025-04-25
MNE	Orthosis, Moldable, Supportive, Skin Protective	Physical Medicine	Class 1	890.3475	2014-09-16
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	1978-07-20

Official Correspondent

Connor CASE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PEDIFIX, 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 2431499. Last updated year: 2026. Please use registration number 2431499 when referencing this establishment in official correspondence.