FDA.report

CONAIR

Primary DI
00074108295293
Brand
CONAIR
Company
CONAIR CORPORATION
Model
FB27B
Device description
Footbath
Published
2022-04-25
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

Related Records

Product Codes

CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications

CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00074108295293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00074108295293000741082952930741082952930074108295293

GMDN Terms

TermDefinition
Foot bathA mains electricity (AC-powered) device designed to be filled with water to provide therapeutic heat treatment specifically to the feet. It typically consists of a unit with a wide stable base that stands on the floor and includes a shallow receptacle in the centre for the user to place their feet. It has a heating element with thermostat that heats the water to a selected temperature. Some types may have therapeutic foot massage capabilities. This device is intended to relieve foot pain (e.g., ankle joint pain from sprains), as well as headaches, coughs, and other cold symptoms.

Sterilization Methods

Method

Regulatory Flags

DUNS number
001661222
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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

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00074108319005ConairHM122024-04-03
00079642314868CONAIRA314862024-03-25
00079642317463ConairA31746UL2024-03-25
00074108500540CONAIRHM162024-03-18
00074108488268ConairHM092024-02-29
00074108356581CONAIRWW3462024-01-15
00074108452917CONAIRHP01XG2024-01-05
00074108451200CONAIRWW714ZF2023-07-17
00074108453457CONAIRWW715ZF2023-07-17
00074108454584ConairITH902023-07-17
00074108458995CONAIRWW934ZF2023-07-17

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