FDA.reportPublic FDA data

HOMEDICS

Primary DI
00031262093516
Brand
HOMEDICS
Company
FKA DISTRIBUTING CO., LLC
Model
NMS-377HJ
Device description
Shiatsu & Vibration Neck Massager
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
10031262093513PackageGS14In Commercial Distribution
00031262093516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003126209351310031262093513
00031262093516000312620935160312620935160031262093516

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held electric massagerAn electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

Regulatory Flags#

DUNS number
183280973
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015688927HomedicsTIE-050-BABY2026-05-31
00031262100207HOMEDICSHP-G42AJ2020-08-31
00031262114938HOMEDICSSR-GA800J-WMT2024-06-20
00031262114945HOMEDICS SR-GHD800J-WMT2024-06-20
00031262114952HOMEDICS SR-GKM800J-WMT2024-06-20
00031262111975HOMEDICSSR-GHN800J2024-05-01
00031262111982HOMEDICS SR-GHD800J2024-05-01
00031262112002HOMEDICSSR-GA800J2024-05-01
00031262112026HOMEDICSSR-GEM700J2024-05-01
00031262112088HOMEDICSSR-GKM800J2024-05-01
00031262115874HomedicsSCL-XBC200-BK2025-01-25
00031262115898HomedicsSCL-XBC200-WT2025-01-25
00031262115904HomedicsSCL-BBC200-BK2025-01-25
00031262115911HomedicsSCL-BBC200-WT2025-01-25
00031262115959HomedicsSCL-BBC250-BK2025-01-25
00031262115966HomedicsSCL-BBC250-WT2025-01-25
00031262115997HomedicsSCL-BBC350-BK2025-01-25
00031262116000HomedicsSCL-BBC350-WT2025-01-25
00031262111753HomedicsIFR-95HJ2024-10-31
00031262114518HomedicsIFR-99HJ2024-10-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00045915831424Human TouchHuman Touch, LLCISA2026-01-12
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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
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