SCHOLL'S WELLNESS COMPANY
Registration 3015961134FEI 3015961134Parsippany, NJ
Owner/operator: SCHOLL'S WELLNESS COMPANY
- Complaint File Establishment per 21 CFR 820.198
- Develop Specifications But Do Not Manufacture At This Facility
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
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- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 10
- Added, last 12 months
- 2
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 10
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| GEH | Dr Scholls Freeze Away Pin Point Skin Tag RemoverUnit, Cryosurgical, AccessoriesAdded Jan 16, 2026 | Class 2 | 21 CFR 878.4350 | K251493 |
| GEH | Dr. Scholl's Freeze Away Dual Action Wart RemoverUnit, Cryosurgical, Accessories | Class 2 | 21 CFR 878.4350 | K052259 |
| GEH | Dr Scholls Freeze Away Sub-Zero Wart RemoverUnit, Cryosurgical, AccessoriesAdded Jan 16, 2026 | Class 2 | 21 CFR 878.4350 | K242932 |
| GEH | Dr. Scholl's Freeze Away Wart RemoverUnit, Cryosurgical, Accessories | Class 2 | 21 CFR 878.4350 | K031697 |
| GEH | Dr. Scholl's Freeze Away Max Wart RemoverUnit, Cryosurgical, Accessories | Class 2 | 21 CFR 878.4350 | K201366 |
| GEH | Dr. Scholls Freeze Away Skin Tag RemoverUnit, Cryosurgical, Accessories | Class 2 | 21 CFR 878.4350 | K211099 |
| LYG | Dr Scholls Hot and Cold Massage BallMassager, Therapeutic, Manual | Class 1 | 21 CFR 890.5660 | — |
| KNP | 24 Hour Energy InsolesOrthosis, Corrective Shoe | Class 1 | 21 CFR 890.3475 | — |
| IQI | Dr Scholls 2 in 1 Bunion and Toe CorrectorOrthosis, Limb Brace | Class 1 | 21 CFR 890.3475 | — |
| KGX | DS CUTS & SCRAPES BANDAGES 16CTTape And Bandage, Adhesive | Class 1 | 21 CFR 880.5240 | — |
What changed
- Jan 16, 2026Listing added: GEH — Dr Scholls Freeze Away Pin Point Skin Tag Remover (K251493)
- Jan 16, 2026Listing added: GEH — Dr Scholls Freeze Away Sub-Zero Wart Remover (K242932)