AccessGUDID - DEVICE: BEOKA (06950735801981)

GUDID

Device Identifier (DI) Information

Brand Name: BEOKA
Version or Model: ACM-A1/Beoka/Black(S)/Standard Edition
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SiChuan Qian Li Beoka Medical Technology Co., Ltd.

Primary DI Number: 06950735801981
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 560529502 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
67203	Wearable electric massager	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRP	Massager, Powered Inflatable Tube

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241446	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 374e3547-93b2-48b7-9b57-01c1ef70e296
Public Version Date: November 13, 2024
Public Version Number: 1
DI Record Publish Date: November 05, 2024