Device Desk

Private service · Not FDA

FDA device establishment · Colleyville, TX

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

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Renewal dossierDD-3010632563As of September 30, 2026

EXCELHEALTH INC.

Registration 3010632563FEI 3010632563Colleyville, TX

Owner/operator: ExcelHealth Inc.

  • 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
18
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

  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 18

CodeDeviceClassRegulationPremarket
GXYPre-Gelled Butterfly Electrode Pads, 3.5" x 5", ET-7171, B0148U5E44Electrode, CutaneousAdded Jul 28, 2026Class 221 CFR 882.1320K132588
GXYPre-Gelled Butterfly Electrode Pads, 3.5" x 5", ET-7171, B0148U5E44Electrode, CutaneousClass 221 CFR 882.1320K082065
ILYiReliev PainIQ+ Red Light and Infrared Laser, RL-1000Lamp, Infrared, Therapeutic HeatingAdded Jul 23, 2026Class 221 CFR 890.5500—
NYNiReliev Strength and Recovery System (ET-7070-1, ET-7070, ET-7070-FBA, B011J79PNK, B00USXKC52)Stimulator, Electrical, Transcutaneous, For ArthritisClass 221 CFR 882.5890K141299
NYNiReliev Pain Relief System, Top Best TENS (ET-1313, ET-1313-1, ET-1313-2, ET-1313-CM-5050-4, B00MERK3TU, B00RZRZ36W)Stimulator, Electrical, Transcutaneous, For ArthritisClass 221 CFR 882.5890K172809
NYNPlayMakar Sport Muscle Stimulator, PRO-500Stimulator, Electrical, Transcutaneous, For ArthritisClass 221 CFR 882.5890K182581
NYNPlayMakar PRO Wireless Muscle Stimulator PRO-1000, PRO-1000-2Stimulator, Electrical, Transcutaneous, For ArthritisClass 221 CFR 882.5890K161453
NGXPlayMakar PRO Wireless Muscle Stimulator PRO-1000, PRO-1000-2Stimulator, Muscle, Powered, For Muscle ConditioningClass 221 CFR 890.5850K161453
NGXiReliev Strength and Recovery System (ET-7070-1, ET-7070, ET-7070-FBA, B011J79PNK, B00USXKC52)Stimulator, Muscle, Powered, For Muscle ConditioningClass 221 CFR 890.5850K141299
NGXPlayMakar Sport Muscle Stimulator, PRO-500Stimulator, Muscle, Powered, For Muscle ConditioningClass 221 CFR 890.5850K182581
NGXiReliev Pain Relief System, Top Best TENS (ET-1313, ET-1313-1, ET-1313-2, ET-1313-CM-5050-4, B00MERK3TU, B00RZRZ36W)Stimulator, Muscle, Powered, For Muscle ConditioningClass 221 CFR 890.5850K172809
NUHiReliev Pain Relief System, Top Best TENS (ET-1313, ET-1313-1, ET-1313-2, ET-1313-CM-5050-4, B00MERK3TU, B00RZRZ36W)Stimulator, Nerve, Transcutaneous, Over-The-CounterClass 221 CFR 882.5890K172809

and 6 more on your full dossier

What changed

  • Jul 28, 2026Listing added: GXY — Pre-Gelled Butterfly Electrode Pads, 3.5" x 5", ET-7171, B0148U5E44 (K132588)
  • Jul 23, 2026Listing added: ILY — iReliev PainIQ+ Red Light and Infrared Laser, RL-1000
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

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Keep this desk: $249 a year

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Renews each year until you cancel. Cancel any time from your account.

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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