DEVICE: HealthLight (00858935006020)
Device Identifier (DI) Information
HealthLight
HL-132R
In Commercial Distribution
502002
HEALTHLIGHT LLC
HL-132R
In Commercial Distribution
502002
HEALTHLIGHT LLC
132 LED Pad, Infrared Phototherapy Unit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35147 | Musculoskeletal infrared phototherapy unit, non-wearable |
A mains electricity (AC-powered) device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ILY | Lamp, Infrared, Therapeutic Heating |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
66814f7b-4a8c-452b-85e7-bed8b16a712c
May 08, 2018
3
July 29, 2016
May 08, 2018
3
July 29, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
224-231-0342
cjohl@healthlightllc.com
cjohl@healthlightllc.com