in2
- Primary DI
- 07290018590010
- Brand
- in2
- Company
- Passiflora Inc.
- Model
- VP42-Hi
- Device description
- in2Record
- Published
- 2024-11-18
- 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
- true
Product Codes
| Code | Name |
|---|
| QRC | Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QRC | Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation | Gastroenterology, Urology | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K223595 | 000 | vPATCH | Virility Medical , Ltd. | 2023-05-01 | QRC |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 07290018590010 | Primary | GS1 | 0 | |
| 07290018590003 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 07290018590010 | 07290018590010 | 7290018590010 |
| 07290018590003 | 07290018590003 | 7290018590003 |
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. |
Regulatory Flags
- DUNS number
- 117718753
- Device count
- 2
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- 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 |
|---|
| 07290018590058 | in2 | VP41-Hi | | 2024-12-18 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 07290018590058 | in2 | Passiflora Inc. | QRC | 2024-12-18 |