ViveSole
- Primary DI
- 10810113573103
- Brand
- ViveSole
- Company
- VIVE HEALTH LLC
- Model
- INS1057DBLUL
- Device description
- Shock Absorbing Heel Cup (Large)
- Published
- 2023-06-23
- 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
Related Records
Product Codes
| Code | Name |
|---|---|
| OHI | Orthosis, Foot Drop |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| OHI | Orthosis, Foot Drop | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10810113573103 | Package | GS1 | 120 | In Commercial Distribution |
| 00810113573106 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10810113573103 | 10810113573103 | ||
| 00810113573106 | 00810113573106 | 810113573106 | 0810113573106 |
GMDN Terms
| Term | Definition |
|---|---|
| Foot friction/impact protector | A device designed to be worn over/on the foot, often while wearing shoes, to provide a cushion to protect the whole foot or parts of the foot (e.g., toes, metatarsal heads, heel) from friction against surfaces or knocks against objects, to relieve pain during walking, and/or to prevent formation of hard areas and callouses. It is typically made of soft-padded or gel materials in a variety of forms (e.g., strip, pad, elastic band, digital tube), and some types may be inflatable or held in place with bands or straps around the foot. It is not specifically designed to protect a bunion. This is a reusable device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 047025993
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- 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 |
|---|---|---|---|---|
| 00810178883943 | Vive | SUP3111BLK | 2026-03-06 | |
| 00810178884506 | Vive | MOB1141BLK32 | 2026-03-06 | |
| 00810178884643 | Vive | MOB1142BLK | 2026-03-06 | |
| 00810178884766 | Vive | MOB1144GRY | 2026-03-06 | |
| 00810178884773 | Vive | MOB1144BLU | 2026-03-06 | |
| 00810178884780 | Vive | MOB1144PNK | 2026-03-06 | |
| 00810178885213 | Vive | MOB1139BLK26 | 2026-03-06 | |
| 00810178885220 | Vive | MOB1139BLK28 | 2026-03-06 | |
| 00810178885237 | Vive | MOB1139BLK30 | 2026-03-06 | |
| 00810178887040 | Vive | LVA1004DBLU | 2026-03-06 | |
| 00810178887057 | Vive | LVA2030DBLU | 2026-03-06 | |
| 00810178887392 | Vive Mobility | MOB1079GRY | 2026-02-18 | |
| 00810178886890 | Vive | SUP2019BGEXS | 2026-02-17 | |
| 00810178886906 | Vive | SUP2019BGES | 2026-02-17 | |
| 00810178886913 | Vive | SUP2019BGEM | 2026-02-17 | |
| 00810178886920 | Vive | SUP2019BGEL | 2026-02-17 | |
| 00810178886937 | Vive | SUP2019BGEXL | 2026-02-17 | |
| 00810178886944 | Vive | SUP2019BLKXS | 2026-02-17 | |
| 00810178886951 | Vive | SUP2019BLKS | 2026-02-17 | |
| 00810178886968 | Vive | SUP2019BLKM | 2026-02-17 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00810178883219 | Vive | VIVE HEALTH LLC | OHI | 2026-02-09 |
| 00810178883226 | Vive | VIVE HEALTH LLC | OHI | 2026-02-09 |
| 00810178883233 | Vive | VIVE HEALTH LLC | OHI | 2026-02-09 |
| 10810113575473 | Vive | VIVE HEALTH LLC | OHI | 2024-01-12 |
| 10810113575480 | Vive | VIVE HEALTH LLC | OHI | 2024-01-12 |
| 10810113575497 | Vive | VIVE HEALTH LLC | OHI | 2024-01-12 |
| 00810050250771 | Maramed Orthopedic Systems | BIOSCULPTOR CORPORATION | OHI | 2023-11-29 |
| 00810050250788 | Maramed Orthopedic Systems | BIOSCULPTOR CORPORATION | OHI | 2023-11-29 |
| 00810050250795 | Maramed Orthopedic Systems | BIOSCULPTOR CORPORATION | OHI | 2023-11-29 |
| 00810050250801 | Maramed Orthopedic Systems | BIOSCULPTOR CORPORATION | OHI | 2023-11-29 |
| 00810050250818 | Maramed Orthopedic Systems | BIOSCULPTOR CORPORATION | OHI | 2023-11-29 |
| 00810050250825 | Maramed Orthopedic Systems | BIOSCULPTOR CORPORATION | OHI | 2023-11-29 |
| 00810050250832 | Maramed Orthopedic Systems | BIOSCULPTOR CORPORATION | OHI | 2023-11-29 |
| 00810050250849 | Maramed Orthopedic Systems | BIOSCULPTOR CORPORATION | OHI | 2023-11-29 |
| G144AFO0 | Flint Rehab | Flint Rehabilitation Devices LLC | OHI | 2023-08-10 |
| G505MRES0 | Easy Step | M.A.S.S. Rehab, LLC | OHI | 2023-08-01 |
| 10810113573837 | VIVE | VIVE HEALTH LLC | OHI | 2023-07-24 |
| 10810113573844 | VIVE | VIVE HEALTH LLC | OHI | 2023-07-24 |
| 10810113573851 | VIVE | VIVE HEALTH LLC | OHI | 2023-07-24 |
| 10810041989052 | ViveSole | VIVE HEALTH LLC | OHI | 2023-06-23 |
| 10810041989069 | ViveSole | VIVE HEALTH LLC | OHI | 2023-06-23 |
| 10810041989076 | ViveSole | VIVE HEALTH LLC | OHI | 2023-06-23 |
| 10810113573073 | ViveSole | VIVE HEALTH LLC | OHI | 2023-06-23 |
| 10810113573080 | ViveSole | VIVE HEALTH LLC | OHI | 2023-06-23 |
| 10810113573097 | ViveSole | VIVE HEALTH LLC | OHI | 2023-06-23 |
| 00733657223156 | AFO C-50 LG/RT WM10-11 MN9-12 | ALIMED, INC. | OHI | 2022-12-01 |
| 00733657223767 | MULTIBOOT REGULAR | ALIMED, INC. | OHI | 2022-12-01 |
| 00733657287851 | AFO SWEDISH, WMNS RT NAT 50/CS IF BO SUGGEST BLK AFO 64332 | ALIMED, INC. | OHI | 2022-12-01 |
| 00733657287868 | AFO SWEDISH, WMNS LF NAT 50/CS IF BO SUGGEST BLK AFO 64333 | ALIMED, INC. | OHI | 2022-12-01 |
| 00733657287875 | AFO SWEDISH: MENS RT NAT 50/CS IF BO SUGGEST BLK AFO 64334 | ALIMED, INC. | OHI | 2022-12-01 |