Aura Wellness, LLC (manufacturer, Louisville, KY): 2 new FDA device listings, incl. electromagnetic stimulator for healthy muscle stimulation

Aura Wellness, LLC (Louisville, Kentucky): 2 new FDA device listings, incl. electromagnetic stimulator for healthy muscle stimulation. Its amount of 2 is above the median of 1 (69th percentile). Dated 55 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median

Free preview: all 14 published fields of this record are shown below. Locked: 5 related KY DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentAura Wellness, LLC
RoleManufacturer
Establishment typesManufacture Medical Device
LocationLouisville, KY, US
New listings2
DevicesElectromagnetic Stimulator For Healthy Muscle Stimulation; Stimulator, Muscle, Powered, For Muscle Conditioning
Product codesSGT, NGX
Device classesClass II
Medical specialtiesPhysical Medicine
Brand namesNova HD+
First new listing2026-09-11
Latest new listing2026-09-11
FDA registration number3018608545
Registration expires2026-12-31
amount percentile69th of 2,570 (median 1, 2.0x median)
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL

  • Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
  • Record date: 2026-09-11
  • Data refreshed: 2026-10-28
  • Refunds on request within 14 days

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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT

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Peer benchmark and outreach value: Aura Wellness, LLC and 6 Kentucky peers

  • Kentucky DeviceEstablishmentPulse records like this one: 6
  • Aura Wellness, LLC's amount: 69th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Kentucky peer: $1,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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70 / 100 Score

  • Brings its own devices to market: buys manufacturing, sterilization and QMS help.
  • Class II or III devices: QMS and regulatory demands.
  • U.S. establishment.

What is the DeviceEstablishmentPulse record for Aura Wellness, LLC in Louisville, Kentucky?

Aura Wellness, LLC (Louisville, KY), a manufacturer, added 2 FDA device listings on 2026-09-11.

How does Aura Wellness, LLC compare to other Kentucky DeviceEstablishmentPulse records?

Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 55 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.

Aura Wellness, LLC vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Aura Wellness, LLCLouisville, KY269th2026-09-11
Beacon Biosignals, Inc.Boston, MA377th2026-10-16
Endovascular Engineering, Inc.Menlo Park, CA377th2026-10-14
INNO Holdings Inc.Millcreek, UT377th2026-10-05

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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.

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