Device Desk

Private service · Not FDA

FDA device establishment · Brooklyn, NY

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-3037609256As of September 30, 2026

HARMONY HEALTH TECH INC

Registration 3037609256FEI 3037609256Brooklyn, NY

Owner/operator: Harmony Health Tech 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
19
Added, last 12 months
7

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 19

CodeDeviceClassRegulationPremarket
ILYInfrared Mat, PEMF MatLamp, Infrared, Therapeutic HeatingClass 221 CFR 890.5500—
IRPCold Compression Therapy SystemMassager, Powered Inflatable TubeAdded Jan 22, 2026Class 221 CFR 890.5650K230524
IRPDurable Medical Equipment (DME), Cold Compression Therapy SystemMassager, Powered Inflatable TubeAdded Jun 17, 2026Class 221 CFR 890.5650K253919
IRPSegments Pneumatic Equipment Compression DeviceMassager, Powered Inflatable TubeAdded Apr 2, 2026Class 221 CFR 890.5650K210967
ILODurable Medical Equipment (DME), Cold Compression Therapy SystemPack, Hot Or Cold, Water CirculatingAdded Jun 17, 2026Class 221 CFR 890.5720K253919
ILOwater sacculation, cold therapy systemPack, Hot Or Cold, Water CirculatingAdded Apr 2, 2026Class 221 CFR 890.5720—
PFWUltrasound DeviceStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep HeatClass 221 CFR 890.5300K222098
IPFTranscutaneous Electrical Nerve Stimulator, Joint Stimulator Model SM9116, SM9143Stimulator, Muscle, PoweredClass 221 CFR 890.5850K233067
NGXBone Regrowth Stimulator; STIMULATOR, NERVE TRANSCUTANEOUS.OVER.THE-COUNTER ,FM-B2501,FM-B2503Stimulator, Muscle, Powered, For Muscle ConditioningClass 221 CFR 890.5850K223825
NGXTranscutaneous Electrical Nerve Stimulator, Joint Stimulator Model SM9116, SM9143Stimulator, Muscle, Powered, For Muscle ConditioningClass 221 CFR 890.5850K233067
GZJTranscutaneous Electrical Nerve Stimulator, Joint Stimulator Model SM9116, SM9143Stimulator, Nerve, Transcutaneous, For Pain ReliefClass 221 CFR 882.5890K233067
NUHBone Regrowth Stimulator; STIMULATOR, NERVE TRANSCUTANEOUS.OVER.THE-COUNTER ,FM-B2501,FM-B2503Stimulator, Nerve, Transcutaneous, Over-The-CounterClass 221 CFR 882.5890K223825

and 7 more on your full dossier

What changed

  • Jan 22, 2026Listing added: IRP — Cold Compression Therapy System (K230524)
  • Jun 17, 2026Listing added: IRP — Durable Medical Equipment (DME), Cold Compression Therapy System (K253919)
  • Apr 2, 2026Listing added: IRP — Segments Pneumatic Equipment Compression Device (K210967)
  • Jun 17, 2026Listing added: ILO — Durable Medical Equipment (DME), Cold Compression Therapy System (K253919)
  • Apr 2, 2026Listing added: ILO — water sacculation, cold therapy system
  • Aug 6, 2026Listing added: INN — Orthopaedic Car Seat, Seating system
  • Jan 22, 2026Listing added: IME — Cold Compression Therapy System (K230524)
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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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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