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Scholl's Wellness Company: FDA-registered device maker in Parsippany, NJ, United States, 6 510(k) clearances

Name: Scholl's Wellness Company FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Scholl's Wellness Company is registered with the FDA (registration 3015961134) in Parsippany, NJ, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 22, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015961134
Address: 119 Cherry Hill Road Suite 200, Parsippany, NJ, United States, 07054
Owner or operator: SCHOLL'S WELLNESS COMPANY (10061238)
Roles: Complaint file establishment, Specification developer
First device listed: November 1, 2019
Registered through: 2026
Brand names listed: 24 Hour Energy Insoles, DS ADVANCED RELIEF (All), DS CUTS & SCRAPES BANDAGES 16CT, DS CUTS & SCRAPES BANDAGES 24CT, DS FLAT FEET INSOLE M, DS FLAT FEET INSOLE W, DS Pressure Relief Insole Men, DS Pressure Relief Insole Women and more

Devices it lists

Device	Product code	Class	Role	Source
Massager, Therapeutic, Manual	LYG	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Orthosis, Corrective Shoe	KNP	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Unit, Cryosurgical, Accessories	GEH	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 22, 2025	K251493	Skin Clinic Freeze Point for Warts and Skin Tags	GEH	Substantially Equivalent	Cryoconcepts LP	accessdata.fda.gov
April 15, 2025	K242932	Skin Clinic Nitro Clear Wart Remover	GEH	Substantially Equivalent	Cryoconcepts LP	accessdata.fda.gov
June 17, 2022	K211099	Freezen Clear Skin Clinic Warts & Tags	GEH	Substantially Equivalent	Cryoconcepts LP	accessdata.fda.gov
January 21, 2021	K201366	Forwarts	GEH	Substantially Equivalent	Pronova Laboratories BV	accessdata.fda.gov
December 14, 2005	K052259	DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406	GEH	Substantially Equivalent	Schering-Plough Healthcare Products, Inc.	accessdata.fda.gov
August 29, 2003	K031697	DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226	GEH	Substantially Equivalent	Schering-Plough Healthcare Products, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.