LS Pro Systems

Primary DI
00850061407054
Brand
LS Pro Systems
Company
WELLNESS WITHOUT LIMITS LLC
Model
XL200
Device description
LS Pro Systems Body pad XL 200 red/infrared LED flexi-pad with PEMF. 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, sciatica, and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. It is intended to be applied to the body and emit short-time pulsed, radio-frequency energy [pulsed electromagnetic fields (PEMF)] to tissues at a level below the patient's heat sensory perception threshold. 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
Single use
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850061407054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061407054008500614070548500614070540850061407054

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held deep-tissue electromagnetic stimulatorA battery-powered, hand-held device designed to apply an electromagnetic (EM) field to body deep tissues to help reduce pain associated with musculoskeletal/neurological disorders (e.g., arthritis, sciatica) and/or to treat soft-tissue wounds and injuries with no production of a therapeutic deep heat. It is a self-contained electronic unit with controls intended to be applied to the body to emit short-time pulsed, radio-frequency energy [pulsed electromagnetic fields (PEMF)] to tissues at a level below the patient's heat sensory perception threshold. It is not intended to apply an electric current directly to the body. The device is intended to be used in clinical and home settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
020287489
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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
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
00850061407115LS Pro SystemsB1122024-05-09
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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