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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06927753902426MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902433MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
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06927753902457MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902464MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902471MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902488MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902495MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902501MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902518MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902525MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902532MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902549MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902556MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902563MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902594MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902600MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753906059MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
16927753900009MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
00810140063236RENPHO Foot MassagerJoicom CorporationISA2026-10-27
00810140063243RENPHO Foot MassagerJoicom CorporationISA2026-10-27
06974958310631mitoredlightShenzhen Idea Light LimitedISA2026-10-22
00810140063229Renpho RejuvenJoicom CorporationISA2026-10-20
00810226442610ViveVIVE HEALTH LLCISA2026-10-09
00810226442627ViveVIVE HEALTH LLCISA2026-10-09
00810226442634ViveVIVE HEALTH LLCISA2026-10-09
00810226442641ViveVIVE HEALTH LLCISA2026-10-09
00850018480888Primo PassiPrimo Passi LLCISA2026-09-21
00860014139918QUASONIQ+Global Good, Corp.ISA2026-09-21
06977444420005Shuhai JingweiShuhai Jingwei (Shenzhen) Information Technology Co., Ltd.ISA2026-09-04