Pulse Tec X-17

GUDID 06971712727797

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID06971712727797
NIH Device Record Key9c8fa206-3c38-4dd3-a6c7-e89462b27450
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulse Tec X-17
Version Model NumberSM9116
Company DUNS421286946
Company NameHong Qiangxing (Shen Zhen) Electronics Limited
Device Count48
DM Exempttrue
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 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
GS106971712727797 [Primary]
GS116971712727794 [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 StatusUpdate
Device Record StatusPublished
Public Version Number10
Public Version Date2025-03-04
Device Publish Date2017-04-20

Devices Manufactured by Hong Qiangxing (Shen Zhen) Electronics Limited

06971712727797 - Pulse Tec X-172025-03-04
06971712727797 - Pulse Tec X-172025-03-04
16971712722973 - Numiere2025-02-12
06971712729944 - takoo2025-01-30
16971712727466 - NURSAL2025-01-09 HPTS0237 silver
06971712727759 - Cloudix2025-01-08
06971727219706 - eMP102025-01-08
06971712729647 - TOMMIE COPPER2024-12-11
06971712727452 - TEC.BEAN2024-12-10

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