FDA.reportPublic FDA data

Human Touch

Primary DI
00045915800338
Brand
Human Touch
Company
Human Touch, LLC
Model
PERFECT CHAIR PC-PRO BLACK SOFHYDE, 120V cETL
Catalog number
PC-610-100-01P
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
Rx
false
OTC
true
Sterile
false
Single use
false

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
00045915800338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00045915800338000459158003380459158003380045915800338

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00045915831141Human TouchNOVO FLEX, GRAY100-FLEX-0012024-05-07
00045915831158Human TouchNOVO FLEX, BROWN100-FLEX-0022024-05-07
00045915830274Human TouchHT CIRCA ZG CHAIR, ESPRESSO/OAK100-CIRCA-0012023-08-28
00045915830281Human TouchHT CIRCA ZG CHAIR, LATTE/OAK100-CIRCA-0022023-08-28
00045915010218Human TouchHT RAPTURE CAPP , TRUM SPA LOGO, SQ TRAYHT-RAPTURE-100-0342023-08-24
00045915010225Human TouchHT RAPTURE RED , TRUM SPA LOGO, SQ TRAYHT-RAPTURE-100-0352023-08-24
00045915010232Human TouchHT RAPTURE CREAM, TRUM SPA LOGO, SQ TRAYHT-RAPTURE-100-0362023-08-24
00045915010249Human TouchHT RAPTURE ESPRESSO, TRUM SPA LOGO, SQ TRAYHT-RAPTURE-100-0372023-08-24

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