FDA.reportPublic FDA data

Adjustor

Primary DI
00858985006155
Brand
Adjustor
Company
ERCHONIA CORPORATION, LLC
Model
VA3
Catalog number
VA3
Device description
THERAPEUTIC – Handheld Variable Adjuster – IFU adjunctive use for treatment of symptoms associate with pain
Published
2020-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858985006155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858985006155008589850061558589850061550858985006155

GMDN Terms#

Term, Definition table
TermDefinition
Circulatory/musculoskeletal vibration therapy unit, platformA portable, electrically-powered device designed as a standing platform/plate for delivery of therapeutic low-magnitude vibrations throughout the body to improve musculoskeletal structure/function and enhance blood and lymphatic flow. It may be intended as a treatment for osteoporosis or to improve posture, coordination, and balance by using high-frequency, low-intensity mechanical vibrations according to the user’s body mass/dynamics. The device is intended to be used in clinical and home settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004053174
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858985006360EVRL-OTCEVRL3-OTC2026-02-09
00858985006292Erchonia Zerona VZ8VZ82025-02-25
00858985006193FX405MLS-AC2020-08-10
00858985006278Erchonia GVLGVL2022-10-31
00858985006186FX635HPS2HPS22020-06-19
00858985006001Base StationBSTBST2016-09-24
00858985006025EVLEVLEVL2016-09-24
00858985006032EVRLEVRLEVRL2016-09-24
00858985006049FX635HPSHPS2016-09-24
00858985006063PL TouchPLTPLT2016-09-24
00858985006087VLSVLSVLS2016-09-24
00858985006094XLR8HLSHLS2016-09-24
00858985006261Erchonia Zerona Z-BedJZB2022-10-31
00858985006162PercussorVP3VP32020-06-19
00858985006018EmeraldSHLSHL2016-09-24
00858985006124Zerona Z6SHRSHR2016-09-24
00858985006100Zerona 2.0GLSGLS2016-09-24
00858985006117Zerona ADARCARC2016-09-24
00858985006056LunulaFFSFFS2016-09-24
00858985006070VerjuCLSCLS2016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00045915831448Human TouchHuman Touch, LLCISA2026-01-12
00045915831455Human TouchHuman Touch, LLCISA2026-01-12
00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.ISA2025-07-15
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