N/A

GUDID 06950940801639

Shenzhen Osto Technology Co.,Ltd.

Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system Acupuncture electrical stimulation system
Primary Device ID06950940801639
NIH Device Record Key8777261f-b830-42f9-8e0c-e1793455c2a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberAST-905B
Company DUNS528161684
Company NameShenzhen Osto Technology Co.,Ltd.
Device Count250
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106950940801615 [Primary]
GS106950940801639 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NGXStimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-04
Device Publish Date2022-03-26

On-Brand Devices [N/A]

06950940801646AST-905D
06950940801639AST-905B
06950940801899AST-2012A
06950940801875AST-300L
06950940801936AST-603

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