FDA.reportPublic FDA data

Human Touch

Primary DI
00045915800383
Brand
Human Touch
Company
Human Touch, LLC
Model
WHOLEBODY 7.1, GRAY, SOFHYDE, TURKEY, XPRESSPA LOG
Catalog number
105-WB71-015
Device description
A 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.
Published
2023-08-23
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
00045915800383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00045915800383000459158003830459158003830045915800383

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
019117691
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00045915831424Human TouchHT SUPER NOVO 3.0, SOFHYDE, CREAM100-SNOVO3-0012026-01-12
00045915831431Human TouchHT SUPER NOVO 3.0, SOFHYDE, ESPRESSO100-SNOVO3-0022026-01-12
00045915831448Human TouchHT SUPER NOVO 3.0, SOFHYDE, GRAY100-SNOVO3-0032026-01-12
00045915831455Human TouchHUMAN TOUCH, VESTA ZG CHAIR, CREAM, BASE100-VESTA-001B2026-01-12
00045915831462Human TouchHUMAN TOUCH, VESTA ZG CHAIR, CREAM, BACKREST100-VESTA-001R2026-01-12
00045915831479Human TouchHUMAN TOUCH VESTA, CHESTNUT, LEA, CHAIR BASE100-VESTA-002B2026-01-12
00045915831486Human TouchHUMAN TOUCH, VESTA ZG CHAIR, CHESTNUT, BACKREST100-VESTA-002R2026-01-12
00045915831493Human TouchPC365 RERCLINER, DARK WALNUT BASE, ESPRESSO PAD, SPC-365-100-0012026-01-12
00045915818869Human TouchNOVO XT PRO PLUS, BLACK, HT SAFE SOFHYDE100-NOVOXTP-0032025-08-13
00045915830588Human TouchNOVO XT PRO SE, BLACK, HT SAFE SOFHYDE100-NOVOXTP-0022025-08-13
00045915831103Human TouchHALE AIR PREMIER DARK WALNUT BASE, MODERN GRAY PAD100-HAP-0032024-09-25
00045915831189Human TouchHALE AIR PREMIER DARK WALNUT BASE, AMERICANO PAD100-HAP-0012024-09-25
00045915831196Human TouchHALE AIR PREMIER DARK WALNUT BASE, CARBON PAD100-HAP-0022024-09-25
00045915831219Human TouchHALE AIR PREMIER DARK WALNUT BASE, PALESTONE PAD100-HAP-0042024-09-25
00045915831226Human TouchHALE AIR PREMIER HONEYWOOD BASE, BLUE PAD100-HAP-0052024-09-25
00045915831233Human TouchHALE AIR PREMIER HONEYWOOD BASE, CARAMEL PAD100-HAP-0062024-09-25
00045915831240Human TouchHALE AIR PREMIER HONEYWOOD BASE, SADDLE PAD100-HAP-0072024-09-25
00045915831288Human TouchAIRTECH ZG PRO, HT SAFE SOFHYDE, BLACK100-ATP-0012024-09-25
00045915831110Human TouchSOL PLUS CALF FOOT MASSAGER, BLUE200-SOL-0022024-05-14
00045915830380Human TouchREVEAL OTTOMAN MASSAGER200-REVEAL-0012024-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16973368290059MedisanaZhangzhou Easepal Medical Science And Technology Co., Ltd.ISA2026-04-30
07630039101855MASTERPULS®Storz Medical AGISA2026-04-15
00045915831424Human TouchHuman Touch, LLCISA2026-01-12
00045915831431Human TouchHuman Touch, LLCISA2026-01-12
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
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