FDA.reportPublic FDA data

BEOKA

Primary DI
06950735802025
Brand
BEOKA
Company
SiChuan Qian Li Beoka Medical Technology Co., Ltd.
Model
ACM-A2/Beoka/Black(S)/Standard Edition
Device description
The Air Compression Massager is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Published
2024-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K241446000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241446000Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)Sichuan Qianii-Beoka Medical Technoiogy Lnc.2024-10-08IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06950735802025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950735802025069507358020256950735802025

GMDN Terms#

Term, Definition table
TermDefinition
Wearable electric massagerAn electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It is typically in the form of a wearable wrap containing vibrating nodes that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This is a home-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+86-13551356664baiwei@beoka.com

Regulatory Flags#

DUNS number
560529502
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06950735811607BEOKAACM-A1/Black S (Luxury version)2025-05-08
06950735811614BEOKAACM-A1/Black M (Luxury version)2025-05-08
06950735811621BEOKAACM-A1/Black L (Luxury version)2025-05-08
06950735812390BEOKAACM-PLUS-A2/Black M/Luxury version2025-03-19
06950735812406BEOKAACM-PLUS-A2/Black L/Luxury version2025-03-19
06950735801981BEOKAACM-A1/Beoka/Black(S)/Standard Edition2024-11-05
06950735802018BEOKAACM-A1/Beoka/Black(XL)/Standard Edition2024-11-05
06950735802032BEOKAACM-A2/Beoka/Black(M)/Standard Edition2024-11-05
06950735802049BEOKAACM-A2/Beoka/Black(L)/Standard Edition2024-11-05
06950735802056BEOKAACM-A2/Beoka/Black(XL)/Standard Edition2024-11-05
06950735801998BEOKAACM-A1/Beoka/Black(M)/Standard Edition2024-11-01
06950735802001BEOKAACM-A1/Beoka/Black(L)/Standard Edition2024-11-01

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Primary DI, Brand, Company table
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08809040526783Air Relax Classic Model AR-1.0 Leg Recovery System-Size 2Maxstar Industrial Co.,Ltd.IRP2025-10-01
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