Device Desk

Private service · Not FDA

FDA device establishment · Eastvale, CA

This page shows the yearly renewal for this site, from FDA’s public record.

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-3043009869As of September 30, 2026

SKYWARD MEDICAL DEVICES LLC

Registration 3043009869FEI 3043009869Eastvale, CA

Owner/operator: Skyward Medical Devices LLC

  • Repack or Relabel Medical Device

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

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
29
Added, last 12 months
29

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

  1. 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 process

  2. Wait 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 process

  3. Renew 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 listing

  4. Review 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 29

CodeDeviceClassRegulationPremarket
GCXPortable Suction Machine for Home,Electric Suction MachineApparatus, Suction, Operating-Room, Wall Vacuum PoweredAdded Aug 3, 2026Class 221 CFR 880.6740—
KXQProbe for Pelvic Floor Trainer, Kegel Exerciser Probe for Strengthen Pelvic Floor MuscleVibrator For Therapeutic Use, GenitalAdded Aug 3, 2026Class 221 CFR 884.5960—
FQMElastic Bandage CapBandage, ElasticAdded Aug 3, 2026Class 121 CFR 880.5075—
GBYEustachian Tube Unblocker Ear Pressure Relief DeviceCatheter, Eustachian, General & Plastic SurgeryAdded Aug 3, 2026Class 121 CFR 878.4200—
PHWcold therapy machineCold Pack And Vibrating MassagerAdded Aug 3, 2026Class 121 CFR 890.5975—
IPRCrutchCrutchAdded Aug 3, 2026Class 121 CFR 890.3150—
IONHand ExerciserExerciser, Non-MeasuringAdded Aug 3, 2026Class 121 CFR 890.5370—
KYSInsole,Carbon Fiber FootplateInsoles, MedicalAdded Aug 3, 2026Class 121 CFR 880.6280—
ITWAnkle Brace,Carbon Fiber Ankle Foot Orthosis,TRB-549, Foot Support;Joint, Ankle, External BraceAdded Mar 11, 2026Class 121 CFR 890.3475—
ESEelectrolarynx, TRB-999Larynx, Artificial (Battery-Powered)Added Aug 3, 2026Class 121 CFR 874.3375—
BYFoxygen concentratorMask, Oxygen, Low Concentration, VenturiAdded Aug 3, 2026Class 121 CFR 868.5600—
OEAIsolation GownsNon-Surgical GownAdded Aug 3, 2026Class 121 CFR 878.4040—

and 17 more on your full dossier

What changed

  • Aug 3, 2026Listing added: GCX — Portable Suction Machine for Home,Electric Suction Machine
  • Aug 3, 2026Listing added: KXQ — Probe for Pelvic Floor Trainer, Kegel Exerciser Probe for Strengthen Pelvic Floor Muscle
  • Aug 3, 2026Listing added: FQM — Elastic Bandage Cap
  • Aug 3, 2026Listing added: GBY — Eustachian Tube Unblocker Ear Pressure Relief Device
  • Aug 3, 2026Listing added: PHW — cold therapy machine
  • Aug 3, 2026Listing added: IPR — Crutch
  • Aug 3, 2026Listing added: ION — Hand Exerciser
  • Aug 3, 2026Listing added: KYS — Insole,Carbon Fiber Footplate
  • Mar 11, 2026Listing added: ITW — Ankle Brace,Carbon Fiber Ankle Foot Orthosis,TRB-549, Foot Support;
  • Aug 3, 2026Listing added: ESE — electrolarynx, TRB-999
  • Aug 3, 2026Listing added: BYF — oxygen concentrator
  • Aug 3, 2026Listing added: OEA — Isolation Gowns
  • Aug 3, 2026Listing added: IQK — Cervical Collar; Neck Traction,Cervical Traction Device TRB-844
  • Aug 3, 2026Listing added: IQF — Head Cervical Thoracic Orthosis,Cervical Traction Device TRB-844,Pectus Carinatum Brace TRB-510; Pectus Excavatum Vacuum
  • Aug 3, 2026Listing added: KNP — Children Dennis Shoes, Diabetic Shoes, Decompression Shoes, Corrective Shoes
  • Aug 3, 2026Listing added: IQI — Adjustable Knee Orthosis
  • Aug 3, 2026Listing added: IQE — Waist Brace,Lumbar Orthosis, Rib Belt,Correction Belt,Clavicle Strap, Back Brace TRB-481
  • Aug 3, 2026Listing added: IPX — Prosthetic Suspension Belt
  • Aug 3, 2026Listing added: IPT — Hyperextension Brace;Prefabricated Hyperextension Orthosis,TRB-401
  • Aug 3, 2026Listing added: MRI — Shoulder Orthosis ,Shoulder Brace
  • Aug 3, 2026Listing added: PCM — portable oxygen unit TRB-140
  • Aug 3, 2026Listing added: HOY — Goggles
  • Aug 3, 2026Listing added: KPY — Face Shield
  • Aug 3, 2026Listing added: IPG — shoe cast
  • Aug 3, 2026Listing added: ILI — Arm Sling
  • Aug 3, 2026Listing added: ILH — Adjustable Thoracolumbar Orthosis, Glove,Wrist brace Forearm Support; Stroke Splint,Boxer Splint Hand Splint,Finger Splint
  • Aug 3, 2026Listing added: IOY — Adjustable Elbow Brace
  • Aug 3, 2026Listing added: EHY — Impression Foam Box
  • Aug 3, 2026Listing added: FSM — Prosthetic Components,Prosthetic Parts
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

Read FDA’s page on registration

Watch for mail that looks like it is from FDA and asks you to pay a company. You pay FDA’s fee only in FDA’s own system.

Keep this desk: $249 a year

We keep this page current each week. We email you before each date in the window, and when FDA’s record shows you renewed.

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Is this right?

We copy this from FDA’s public record. FDA’s own record always wins. A listing missing here does not prove anything about FDA’s record.

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