Megawise

GUDID 06971712720255

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID06971712720255
NIH Device Record Keyf63fa476-a317-49e9-a1d4-2ebb3ab3ef90
Commercial Distribution StatusIn Commercial Distribution
Brand NameMegawise
Version Model NumberTENS
Company DUNS421286946
Company NameHong Qiangxing (Shen Zhen) Electronics Limited
Device Count32
DM Exemptfalse
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
GS106971712720248 [Primary]
GS106971712720248 [Primary]
GS106971712720248 [Primary]
GS106971712720248 [Primary]
GS106971712720248 [Primary]
GS106971712720248 [Primary]
GS106971712720248 [Primary]
GS106971712720248 [Primary]
GS106971712720248 [Primary]
GS106971712720248 [Primary]
GS106971712720248 [Primary]
GS106971712720248 [Primary]
GS106971712720248 [Primary]
GS106971712720248 [Primary]
GS106971712720255 [Unit of Use]
GS106971712720255 [Unit of Use]
GS106971712720255 [Unit of Use]
GS106971712720255 [Unit of Use]
GS106971712720255 [Unit of Use]
GS106971712720255 [Unit of Use]
GS106971712720255 [Unit of Use]
GS106971712720255 [Unit of Use]
GS106971712720255 [Unit of Use]
GS106971712720255 [Unit of Use]
GS106971712720255 [Unit of Use]
GS106971712720255 [Unit of Use]
GS106971712720255 [Unit of Use]
GS106971712720255 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

Devices Manufactured by Hong Qiangxing (Shen Zhen) Electronics Limited

06971712728121 - Xpoint2020-08-14
06971712728107 - Xpoint2020-08-13
06971712728145 - Spine Health2020-08-13
06971712720231 - Nurokor2020-07-31
06971712720255 - Megawise2020-07-31
06971712720255 - Megawise2020-07-31
06971712728084 - DOMAS2020-07-31
06971712720217 - MedTENS2020-07-29
06971712723188 - Uthlusty2020-07-14

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