FDA.reportPublic FDA data

N motion

Primary DI
08800091150620
Brand
N motion
Company
Nuga Medical Co.,Ltd.
Model
N7-S
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08800091150620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800091150620088000911506208800091150620

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
690034673
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800091150132NUGABESTN5-1N51-DM-11-2-022-01A-22022-09-28
08800091121026NUGABESTT20PT20P-DM-11-2-022-01A-02022-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08800091150132NUGABESTNuga Medical Co.,Ltd.JFB2022-09-28
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