IF-5000 Retail

GUDID 00858688006117

Emsi

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00858688006117
NIH Device Record Key71b18a60-c163-4009-beb4-69046ac73f8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameIF-5000 Retail
Version Model NumberSRCOMBOR
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858688006117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LIHInterferential Current Therapy

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 Date2016-09-30

Devices Manufactured by Emsi

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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

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