FX635 HPS

GUDID 00858985006049

MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - IFU Reduction of Musculoskeletal Pain

ERCHONIA CORPORATION, LLC

Musculoskeletal/physical therapy laser, professional
Primary Device ID00858985006049
NIH Device Record Key9d97be3a-90f4-4768-b766-693b1924d3eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFX635
Version Model NumberHPS
Catalog NumberHPS
Company DUNS004053174
Company NameERCHONIA CORPORATION, LLC
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com
Phone(888) 242-0571
Emailinfo@erchonia.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858985006049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHNPowered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-09-09
Device Publish Date2016-09-24

On-Brand Devices [FX635]

00858985006049MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - IFU Reduction of Musculoskeletal
00858985006186MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - IFU Pain Reduction

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