LS Pro Systems
- Primary DI
- 00850061407160
- Brand
- LS Pro Systems
- Company
- WELLNESS WITHOUT LIMITS LLC
- Model
- XL200-SI
- 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.
- 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
| Code | Name |
|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00850061407160 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00850061407160 | 00850061407160 | 850061407160 | 0850061407160 |
GMDN Terms
| Term | Definition |
|---|---|
| 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. |
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 DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00850061407122 | LS Pro Systems | PB-MXP100 | 2024-06-27 | |
| 00850061407139 | LS Pro Systems | PB-MXP171 | 2024-06-27 | |
| 00850061407207 | LS Pro Systems | DSD120 | 2024-06-27 | |
| 00850061407009 | LS Pro Systems | XP1 | 2024-05-09 | |
| 00850061407016 | LS Pro Systems | XP3 | 2024-05-09 | |
| 00850061407023 | LS Pro Systems | XP6 | 2024-05-09 | |
| 00850061407030 | LS Pro Systems | G264 | 2024-05-09 | |
| 00850061407047 | LS Pro Systems | G264B | 2024-05-09 | |
| 00850061407054 | LS Pro Systems | XL200 | 2024-05-09 | |
| 00850061407061 | LS Pro Systems | L132 | 2024-05-09 | |
| 00850061407078 | LS Pro Systems | L132B | 2024-05-09 | |
| 00850061407085 | LS Pro Systems | F104 | 2024-05-09 | |
| 00850061407092 | LS Pro Systems | T90 | 2024-05-09 | |
| 00850061407108 | LS Pro Systems | H155 | 2024-05-09 | |
| 00850061407115 | LS Pro Systems | B112 | 2024-05-09 | |
| 00850061407153 | LS Pro Systems | G264-SI | 2024-05-09 | |
| 00850061407177 | LS Pro Systems | H155-SI | 2024-05-09 | |
| 00850061407184 | LS Pro Systems | UB128-SI | 2024-05-09 | |
| 00850061407191 | LS Pro Systems | LB114-SI | 2024-05-09 | |
| 00850061407214 | LS Pro Systems | F122-SI | 2024-05-09 |
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