FDA.reportPublic FDA data

Motion Space

Primary DI
06976019120364
Brand
Motion Space
Company
Huizhou XINYI Technology Co., LTD
Model
YY-A01L
Device description
Air Compression Leg Massager(Pair)
Published
2024-10-05
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
IRPMassager, Powered Inflatable Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240981000Air compression leg massagerHuizhou Xinyi Technology Co., Ltd.2024-08-02IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976019120364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976019120364069760191203646976019120364

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic massagerAn pneumatically-powered device with a vibrating head mechanism which is typically held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head or pads may be interchangeable with others of different size and shape. It can be used for respiratory and physiotherapy treatment, typically in a hospital or institution, but is also suitable for home-use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
707980076
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00031262116291HomedicsSR-CMXKF10HJ2025-02-01
00031262116697HomedicsSR-CMK5SHJ2025-01-01
00031262116666HomedicsSR-CMX10JA2024-12-31
00031262109507HomedicsSR-CMK10HJ2024-11-12
06976019120371Motion SpaceYY-A01L2024-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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