TOP SHELF MANUFACTURING, LLC
Registration 3003890514FEI 3003890514Tracy, CA
Owner/operator: TOP SHELF MANUFACTURING, LLC
- Manufacture Medical Device
- Manufacture Medical Device for Another Party (Contract Manufacturer)
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
90days left in the window
The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 21
- Added, last 12 months
- 0
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 21
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| OOK | Dermal Cooling Pack/Vacuum/MassagerGeneral, Plastic Surgery | Class 2 | 21 CFR 878.4340 | — |
| ILO | Sierra Cold Therapy System Multiuse Pad, Sierra Cold Therapy System Knee PadPack, Hot Or Cold, Water Circulating | Class 2 | 21 CFR 890.5720 | — |
| HST | Shoulder HolderApparatus, Traction, Non-Powered | Class 1 | 21 CFR 888.5850 | — |
| FSD | 9" Universal Abdominal BinderBinder, Abdominal | Class 1 | 21 CFR 880.5160 | — |
| KQZ | Compact Sleeve, Traction Sleeve, Standard Sleeve, Standard Sleeve w/StrapComponent, Traction, Non-Invasive | Class 1 | 21 CFR 888.5890 | — |
| IOD | CPM Pads, SYSTEM Kit, TEAM Kit, FLEX KitComponents, Exercise | Class 1 | 21 CFR 890.5350 | — |
| IPM | The ProtectorCover, Limb | Class 1 | 21 CFR 890.3025 | — |
| IPR | CrutchCrutch | Class 1 | 21 CFR 890.3150 | — |
| ITW | Ankle Stabilizer, The Gauntlet Ankle Stabilizer, The Gauntlet Pro Ankle Stabilizer, Hinged Ankle StabilizerJoint, Ankle, External Brace | Class 1 | 21 CFR 890.3475 | — |
| ITS | Hip ROM Post-Op BraceJoint, Hip, External Brace | Class 1 | 21 CFR 890.3475 | — |
| ITQ | Adjustable Patella Buttress w/Contour Hinge, Adjustable Patella Buttress, Economy Hinged Knee, Sports CoverJoint, Knee, External Brace | Class 1 | 21 CFR 890.3475 | — |
| IQK | Tracy Collar, Cervical CollarOrthosis, Cervical | Class 1 | 21 CFR 890.3490 | — |
and 9 more on your full dossier
What changed
Nothing added in the last twelve months, and no change seen on the record yet.