FDA.report

LS Pro Systems

Primary DI
00850061407115
Brand
LS Pro Systems
Company
WELLNESS WITHOUT LIMITS LLC
Model
B112
Device description
LS Pro Systems Boot Pad 112 red/infrared LED flexi-pad. Intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Must be used with LS power controller.
Published
2024-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications

CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850061407115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061407115008500614071158500614071150850061407115

GMDN Terms

TermDefinition
Red/infrared light phototherapy unitAn electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.

Sterilization Methods

Method

Regulatory Flags

DUNS number
020287489
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850061407122LS Pro SystemsPB-MXP1002024-06-27
00850061407139LS Pro SystemsPB-MXP1712024-06-27
00850061407207LS Pro SystemsDSD1202024-06-27
00850061407009LS Pro SystemsXP12024-05-09
00850061407016LS Pro SystemsXP32024-05-09
00850061407023LS Pro SystemsXP62024-05-09
00850061407030LS Pro SystemsG2642024-05-09
00850061407047LS Pro SystemsG264B2024-05-09
00850061407054LS Pro SystemsXL2002024-05-09
00850061407061LS Pro SystemsL1322024-05-09
00850061407078LS Pro SystemsL132B2024-05-09
00850061407085LS Pro SystemsF1042024-05-09
00850061407092LS Pro SystemsT902024-05-09
00850061407108LS Pro SystemsH1552024-05-09
00850061407153LS Pro SystemsG264-SI2024-05-09
00850061407160LS Pro SystemsXL200-SI2024-05-09
00850061407177LS Pro SystemsH155-SI2024-05-09
00850061407184LS Pro SystemsUB128-SI2024-05-09
00850061407191LS Pro SystemsLB114-SI2024-05-09
00850061407214LS Pro SystemsF122-SI2024-05-09

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