Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015961134

FEI Number

3015961134

Entity Name

SCHOLL'S WELLNESS COMPANY

City/State/Country

Parsippany, NJ, US

Establishment Address

119 Cherry Hill Road, Suite 200, Parsippany, NJ 07054, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

SCHOLL'S WELLNESS COMPANY (Owner Number: 10061238)

Owner / Operator Contact Address

119 Cherry Hill Road, Suite 200, Parsippany, NJ 07054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Freeze Away Max Plantar Wart Remover Dr. Scholl's Freeze Away Max Wart Remover Dr.Scholl's Blister Treatment Cushions with Durgel Technology Dr Scholls Bunion Cushions Dr Scholls Callus Cushions Dr Scholls Corn Cushions DS CUTS & SCRAPES BANDAGES 24CT DS CUTS & SCRAPES BANDAGES 16CT Dr Scholls Hot and Cold Massage Ball Dr Scholls Freeze Away Sub-Zero Wart Remover Dr. Scholls Freeze Away Skin Tag Remover Freeze Away Skin Tag Remover Enhanced Freeze Away Skin Tag Remover Mini Dr. Scholl's Freeze Away Dual Action Wart Remover Dr Scholls Freeze Away Pin Point Skin Tag Remover Plantar Fasciitis Arch Support Sleeve Dr Scholls 2 in 1 Bunion and Toe Corrector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2021-02-02
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2019-11-01
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2020-01-27
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2026-01-16
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2022-10-19
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-11-01
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2026-01-16
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2022-10-19

Official Correspondent

Alex Terranova

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SCHOLL'S WELLNESS COMPANY

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190651	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	2020-01-07
K760953	Spembly Medical , Ltd.	DEEP FREEZE SYSTEM (DFS-30)	1976-11-16
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29

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3010140265	CSA Medical	Lexington, MA, US
3012697079	COOL RENEWAL, LLC	Nashville, TN, US
3015612252	INTUITIVE SURGICAL, INC.	Santa Clara, CA, US
3010242262	KONINKLIJKE (ROYAL) UTERMOHLEN N.V.	Wolvega Fryslan, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015961134. Last updated year: 2026. Please use registration number 3015961134 when referencing this establishment in official correspondence.