Motive Lower Back 4-Pack Bundle
- Primary DI
- 00850022650550
- Brand
- Motive Lower Back 4-Pack Bundle
- Company
- Motive Health, Inc.
- Model
- OT02-3000
- Catalog number
- OT02-3000
- Device description
- Motive Lower Back 4-Pack Bundle
- Published
- 2025-11-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00850022650550 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00850022650550 | 00850022650550 | 850022650550 | 0850022650550 |
GMDN Terms
| Term | Definition |
|---|
| Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Atmospheric Pressure | 50 KiloPascal | 106 KiloPascal | |
| Handling Environment Humidity | 10 Percent (%) Relative Humidity | 90 Percent (%) Relative Humidity | |
| Handling Environment Temperature | -13 Degrees Fahrenheit | 158 Degrees Fahrenheit | |
| Storage Environment Atmospheric Pressure | 50 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 10 Percent (%) Relative Humidity | 90 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -13 Degrees Fahrenheit | 158 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 035596579
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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