TENS 2500

GUDID 00858688006308

Emsi

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00858688006308
NIH Device Record Key867f4468-a848-440d-9b9c-7129f2090163
Commercial Distribution StatusIn Commercial Distribution
Brand NameTENS 2500
Version Model NumberTENS-2500D
Company DUNS932471881
Company NameEmsi
Device Count1
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858688006308 [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 Date2016-09-08

Devices Manufactured by Emsi

00085971800729 - Hypoallergenic Electrode 2x2 4pk2024-08-26
00858688006964 - Electrode 45 x 45 16 PK2023-09-28
00858688006971 - Electrode 1.75 x 1.75 4 pack 2023-09-28
00859718007074 - Electrode 1.75 x 1.75 - 24 PK2023-09-28
00859718007081 - Electrode 4.0 x 7.0- Dispersive2023-09-28
00859718007098 - Electrode 1 Inch Round 4 PK2023-09-28
00859718007104 - Electrode 2" round 4pk2023-09-28
00859718007111 - Electrode 3 Inch Round 4PK2023-09-28

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