LS Pro Systems

Basic Information

• Brand Name: LS Pro Systems
• Primary DI: 00850061407160
• Version / Model: XL200-SI
• Company Name: WELLNESS WITHOUT LIMITS LLC
• Labeler DUNS: 020287489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-09
• Public Version: 1
• Public Version Date: 2024-05-17
• Public Version Status: New
• Public Device Record Key: d1212735-9a6e-4c42-add1-0bb5012330b8

Device Description

LS Pro Systems Body pad XL in Silicone 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35169	Hand-held deep-tissue electromagnetic stimulator	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850061407160	GS1