Device Desk

Private service · Not FDA

FDA device establishment · Naples, FL

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-3011191255As of September 30, 2026

VIVE Health LLC

Registration 3011191255FEI 3011191255Naples, FL

Owner/operator: VIVE Health LLC

  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • 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
180
Added, last 12 months
104

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 180

CodeDeviceClassRegulationPremarket
MNWDigital Scale with Smart Phone CapabilityAnalyzer, Body CompositionClass 221 CFR 870.2770K122976
PUHBody Fat Scale Compatible with Smart DevicesAnalyzer, Body Composition, ExemptClass 221 CFR 870.2770—
DXQSphygmomanometerBlood Pressure CuffClass 221 CFR 870.1120K092245
DXQBPM DMD1038Blood Pressure CuffClass 221 CFR 870.1120K171889
DXQDMD1013 SphygmomanometerBlood Pressure CuffClass 221 CFR 870.1120K082542
INOLift ChairChair, Positioning, ElectricClass 221 CFR 890.3110K091578
SDVInfrared ThermometerClinical Electronic ThermometerClass 221 CFR 880.2910—
FLLDual ThermometerContinuous Measurement ThermometerClass 221 CFR 880.2910K181239
FLLOral ThermometerContinuous Measurement ThermometerClass 221 CFR 880.2910K051699
FLLInfrared ThermometerContinuous Measurement ThermometerClass 221 CFR 880.2910K171578
FLLOral Thermometer Large DisplayContinuous Measurement ThermometerClass 221 CFR 880.2910K153149
FRZElectric Patient LiftDevice, Patient Transfer, PoweredAdded Mar 5, 2026Class 221 CFR 880.6775—

and 168 more on your full dossier

What changed

  • Mar 5, 2026Listing added: FRZ — Electric Patient Lift
  • Mar 5, 2026Listing added: CAW — Portable Oxygen Concentrator Juniper AC Adapter (K242736)
  • Mar 5, 2026Listing added: FNG — Core Hydraulic Patient Lift
  • Mar 19, 2026Listing added: IRP — Portable Sequential Compression System (K240981)
  • Mar 19, 2026Listing added: QRL — Easy Twist Lancets (K222034)
  • Mar 5, 2026Listing added: CAF — Compressor Nebulizer (Disposable Kit) (LVA3131BRND) (K043238)
  • Mar 16, 2026Listing added: DQA — Pulse Oximeter Compatible with Smart Devices DMD1046 (K161938)
  • Nov 21, 2025Listing added: DQA — TeleRPM Pulse Oximeter 4G (K172141)
  • Mar 4, 2026Listing added: HGX — Breast Pump Dual (K191802)
  • May 6, 2026Listing added: HGX — Hands Free Breast Pump (Model S21) (K250368)
  • Mar 23, 2026Listing added: FMK — Push-Button Safety Lancets 28G (K222408)
  • Mar 19, 2026Listing added: QRK — Easy Twist Lancets (K222034)
  • Mar 19, 2026Listing added: NYN — 60 Mode TENS and EMS Unit (K233092)
  • Mar 12, 2026Listing added: IPF — Wireless TENS and EMS Unit RHB3052 (K233067)
  • Mar 19, 2026Listing added: IPF — 60 Mode TENS and EMS Unit (K233092)
  • Mar 12, 2026Listing added: IPF — EMS TENS Unit RHB2026 (K192087)
  • Mar 5, 2026Listing added: NGX — 8 Mode TENS Unit RHB1006 (K201354)
  • Mar 12, 2026Listing added: NGX — Wireless TENS and EMS Unit RHB3052 (K233067)
  • Mar 12, 2026Listing added: NGX — EMS TENS Unit RHB2026 (K192087)
  • Mar 12, 2026Listing added: NGX — 50 Mode TENS and EMS RHB3004 (K200177)
  • Mar 19, 2026Listing added: NGX — 60 Mode TENS and EMS Unit (K233092)
  • Mar 12, 2026Listing added: GZJ — EMS TENS Unit RHB2026 (K192087)
  • Mar 19, 2026Listing added: GZJ — 60 Mode TENS and EMS Unit (K233092)
  • Mar 12, 2026Listing added: GZJ — Wireless TENS and EMS Unit RHB3052 (K233067)
  • Mar 12, 2026Listing added: NUH — EMS TENS Unit RHB2026 (K192087)
  • Mar 12, 2026Listing added: NUH — Wireless TENS and EMS Unit RHB3052 (K233067)
  • Mar 12, 2026Listing added: NUH — 50 Mode TENS and EMS RHB3004 (K200177)
  • Mar 19, 2026Listing added: NUH — 60 Mode TENS and EMS Unit (K233092)
  • Mar 5, 2026Listing added: NUH — 8 Mode TENS Unit RHB1006 (K201354)
  • Feb 20, 2026Listing added: DXN — TeleRPM BPM (K202891)
  • Feb 20, 2026Listing added: DXN — Blood Pressure Monitor Smart Phone Compatible DMD1092 DMD1094 (K220886)
  • Mar 19, 2026Listing added: DXN — Blood Pressure Monitor DMD1068 (K170466)
  • Mar 19, 2026Listing added: DXN — Standard Blood Pressure Monitor DMD1087 (K222125)
  • Mar 31, 2026Listing added: DXN — Blood Pressure Monitor DMD1001 (K232713)
  • Feb 20, 2026Listing added: DXN — Wrist BPM DMD1063 (K200346)
  • Mar 19, 2026Listing added: DXN — Blood Pressure Monitor DMD1064 (K182495)
  • Mar 16, 2026Listing added: NBW — Blood Glucose Monitor DMD1079 (K191657)
  • Mar 5, 2026Listing added: INI — 3 Wheel Mobility Scooter (K240012)
  • Mar 5, 2026Listing added: INI — King Neptune Mobility Scooter MOB1128 (K251638)
  • Jul 20, 2026Listing added: INI — 3 Wheel Mobility Scooter (MOB1025) (K240008)
  • Mar 5, 2026Listing added: INI — Neptune Mobility Scooter MOB1126 (K182411)
  • Mar 20, 2026Listing added: INI — Mobility Scooter Series A MOB1053 (K062646)
  • Jul 20, 2026Listing added: INI — Mobility Scooter Series A (MOB1053) (K231428)
  • Mar 5, 2026Listing added: ITI — Air Frame Power Wheelchair - Magnesium Collection MOB1125 (K242471)
  • Mar 5, 2026Listing added: ITI — Air Frame Aluminum Power Wheelchair MOB1107 (K242791)
  • Mar 5, 2026Listing added: ITI — Carbon Crossover Power Wheelchair MOB1123 (K240913)
  • Jul 20, 2026Listing added: ITI — Power Wheelchair (MOB1029) (K231508)
  • Mar 5, 2026Listing added: ITI — Power Wheelchair Model C MOB1094 (K232783)
  • Mar 5, 2026Listing added: ITI — AirCarbon Power Wheelchair MOB1140 (K240255)
  • Mar 20, 2026Listing added: ITI — Electric Wheelchair Model V MOB1054 (K130982)
  • Mar 20, 2026Listing added: ITI — FloTilt Power Wheelchair MOB1138 (K251159)
  • Mar 20, 2026Listing added: ILW — Long Handled Toe Washer Kit
  • Mar 12, 2026Listing added: ISR — Diabetic Armband
  • Mar 12, 2026Listing added: ITG — Cast Tape
  • Mar 12, 2026Listing added: FQM — Dr. Pat's Cold Compression Bandage
  • Mar 12, 2026Listing added: NEC — Skin Protectant Wipes
  • Mar 12, 2026Listing added: MDR — Abdominal Binder 2 Panel
  • Mar 20, 2026Listing added: IMW — Brake Handle Extensions
  • Mar 5, 2026Listing added: INM — Air Frame Wheelchair
  • Mar 5, 2026Listing added: EFT — Denture Cleaning Tablets
  • Feb 25, 2026Listing added: IOD — Calf Stretcher
  • Mar 11, 2026Listing added: KIA — Arm Cast Cover
  • Mar 5, 2026Listing added: IPR — Crutches
  • Mar 12, 2026Listing added: MHW — Arthritis Gloves
  • Mar 12, 2026Listing added: NAE — Island Dressing
  • Mar 17, 2026Listing added: NAD — Hydrocolloid Bordered Dressing (Sterile)
  • Mar 12, 2026Listing added: MDA — Silicone Scar Tape
  • Aug 12, 2026Listing added: ION — Resistance Bands
  • Mar 5, 2026Listing added: QDO — Nitrile Exam Gloves (K200019)
  • Dec 1, 2025Listing added: NAB — Drain Sponge
  • Mar 5, 2026Listing added: NDA — Fall Protection Helmet
  • Mar 12, 2026Listing added: ITS — ROM Hip Brace
  • Mar 19, 2026Listing added: IKY — Gel Mattress Overlay
  • Mar 5, 2026Listing added: LZC — Nitrile Exam Gloves (K200019)
  • Dec 1, 2025Listing added: IQI — 760 ROM Elbow Brace
  • Dec 23, 2025Listing added: IPT — 456 TLSO
  • Mar 17, 2026Listing added: MRI — Scoliosis Brace
  • Mar 12, 2026Listing added: IMA — Moist Heat Pack
  • Dec 1, 2025Listing added: IME — 14x13" Ice Wrap
  • Mar 5, 2026Listing added: LZA — Nitrile Exam Gloves (K200019)
  • Mar 4, 2026Listing added: EXE — Abdominal Ostomy Belt
  • Dec 1, 2025Listing added: JOK — Ostomy Scissors
  • Mar 12, 2026Listing added: ILI — 670 Advanced Arm Sling
  • Mar 12, 2026Listing added: KOX — Adhesive Remover Wipes
  • Mar 5, 2026Listing added: FOX — IV Pole
  • Mar 12, 2026Listing added: ILG — Multi Purpose Support Wraps
  • Mar 12, 2026Listing added: FQL — Arm Compression Gauntlet 20-30mmHg
  • Mar 12, 2026Listing added: IOY — Wrist Brace
  • Mar 5, 2026Listing added: QGC — Catheter Bag Holder
  • Mar 11, 2026Listing added: KGX — Kinesiology Tape
  • Jun 18, 2026Listing added: BYX — CPAP Hose
  • Dec 5, 2025Listing added: ILC — Adaptive Adhesive Grip Pads
  • Mar 19, 2026Listing added: IOR — Active Wheelchair MOB1101 (K112816)
  • Mar 16, 2026Listing added: IOR — Sport Wheelchair (K252517)
  • Feb 25, 2026Listing added: IOR — Bariatric Wheelchair (K232198)
  • Mar 16, 2026Listing added: IOR — Pediatric Wheelchair MOB1145 (K053574)
  • Mar 19, 2026Listing added: IOR — Bariatric Wheelchair MOB1141 (K232199)
  • Mar 5, 2026Listing added: IOR — Air Frame Wheelchair MOB1062 (K231110)
  • Mar 17, 2026Listing added: FRO — Xeroform Petrolatum Dressing (K181478)
  • Mar 12, 2026Listing added: FRO — Silver Antimicrobial Wound Gel (K211123)
  • Mar 12, 2026Listing added: FRO — Silver Alginate Dressing (K120181)
  • Nov 21, 2025Listing added: FRO — Wound Cleanser (K231564)
  • Mar 12, 2026Listing added: KGN — Hemostatic Gauze (K143124)
  • Mar 12, 2026Listing added: KGN — Collagen Wound Dressing (K213598)
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.

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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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