Irest Massager

GUDID 10517101000036

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID10517101000036
NIH Device Record Key913929a2-1ff2-44d0-872f-cb3e0739fc4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameIrest Massager
Version Model NumberTENS
Company DUNS421286946
Company NameHong Qiangxing (Shen Zhen) Electronics Limited
Device Count36
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
GS110517101000035 [Unit of Use]
GS110517101000036 [Primary]

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 Date2017-09-28

On-Brand Devices [Irest Massager]

10518021000036TENS
10517101000036TENS
10508225275036TENS

Trademark Results [Irest Massager]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IREST MASSAGER
IREST MASSAGER
87818901 not registered Live/Pending
Kutlug, Adem
2018-03-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.