FDA.reportPublic FDA data

FlowDyn

Primary DI
00860446000336
Brand
FlowDyn
Company
ACI MEDICAL LLC
Model
FD1
Device description
A sports recovery device intended to relieve muscle pain.
Published
2023-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00860446000336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860446000336008604460003368604460003360860446000336

GMDN Terms#

Term, Definition table
TermDefinition
Bed/chair electric massagerA mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.

Contacts#

Phone, Email table
PhoneEmail
7607444400info@acimedical.com

Regulatory Flags#

DUNS number
153761499
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860446000305ArtAssistAA-1000AA-10002016-09-24
00860446000329VenaPulseVP-25VP-252016-09-24
00860446000312APG Air-PlethysmographAPG-1000APG-10002016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
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