DIAMOND MASSAGER

GUDID 00617113000024

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00617113000024
NIH Device Record Key32cd3392-104d-4831-8b10-c8749cf2eea9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIAMOND MASSAGER
Version Model NumberTENS
Company DUNS421286946
Company NameHong Qiangxing (Shen Zhen) Electronics Limited
Device Count24
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100617113000024 [Primary]
GS100617113000025 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-23
Device Publish Date2017-11-30

On-Brand Devices [DIAMOND MASSAGER]

00617113000024TENS
00617103000025TENS
00617006000025TENS

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