FDA.reportPublic FDA data

NUGABEST

Primary DI
08800091150132
Brand
NUGABEST
Company
Nuga Medical Co.,Ltd.
Model
N5-1
Catalog number
N51-DM-11-2-022-01A-2
Device description
Personal heating therapeutic device
Published
2022-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JFBTable, Physical Therapy, Multi Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFBTable, Physical Therapy, Multi FunctionPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153054000N5-1Nuga Medical Co., Ltd.2016-02-05JFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800091150132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800091150132088000911501328800091150132

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight60Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690034673
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800091150620N motionN7-S2025-12-19
08800091121026NUGABESTT20PT20P-DM-11-2-022-01A-02022-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800091150620N motionNuga Medical Co.,Ltd.JFB2025-12-19
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.JFB2025-07-15
08809494000686CERAGEM Master V7CERAGEM Co., Ltd.JFB2025-02-12
08809494000983CERAGEM Master V7CERAGEM Co., Ltd.JFB2025-02-12
08809643652476CERAGEM Master V5CERAGEM Co., Ltd.JFB2025-02-12
08809494000082CERAGEM Master V6CERAGEM Co., Ltd.JFB2021-03-31
08809494000099CERAGEM Master V6CERAGEM Co., Ltd.JFB2021-03-31
08809494000075CERAGEM Master V4CERAGEM Co., Ltd.JFB2021-03-12
00860001452525Air Flex with Auto-DistractionHILL LABORATORIES CO.JFB2020-02-04
B556HY7000U0MigunMIGUN LIFE CO., LTDJFB2017-05-01
B556HY7000UM0MigunMIGUN LIFE CO., LTDJFB2017-05-01
B344HY7000U0MigunMIGUN LIFE INCJFB2017-02-11
B344HY7000UM0MigunMIGUN LIFE INCJFB2016-09-19
08809494000006CERAGEM Master V3CERAGEM Co., Ltd.JFB2016-07-29