DEVICE: FX635 (00858985006049)

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Device Identifier (DI) Information

FX635
HPS
HPS
ERCHONIA CORPORATION, LLC
00858985006049
GS1
1
MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - IFU Reduction Pain, Plantar Fasciitis
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
General therapeutic low-intensity laser, line-powered A mains electricity (AC-powered) diode laser intended to be used to provide low-level laser therapy (LLLT) for a variety of clinical applications (e.g., to treat pain, promote healing of wounds/injuries/disorders of the joints and soft/connective tissues, for non-needle acupuncture). It typically consists of an electronic control unit which may be mounted on a mobile (on wheels) trolley, with a connected applicator to generate laser light in the range of visible red/infrared frequencies (e.g., 650 – 685 nm, 660 - 980 nm). It is intended to be operated by a healthcare provider in a clinical setting.
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FDA Product Code

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Product Code Product Code Name
NHN Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 24, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
(888) 242-0571
info@erchonia.com
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