ViveSole
Heavy Duty Gel Insole (Black) Medium
34manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (13), Zhejiang (6), Shanghai (4). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Dongguan Suscong Healthcare Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Guangzhou Lead Fair Plastic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Tianjin Tairuibosi Medical Appliance Co., Ltd. | Tianjin | Tianjin | Private-label distributor | 30 |
| Suzhou Sunmed Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 28 |
Showing 12 of 34. All 34 manufacturers in China registered for Insoles, Medical
Record
| Listed by | Vive Health LLC, United States |
|---|---|
| FDA product code | KYS |
| Device type | Insoles, Medical |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6280 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-04-24 |
| Record revised | 2020-07-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Packaging | Case of 150, case of 72, case of 80, case of 55, case of 75, case of 120 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| INS1056BLK5XL | In distribution | |
| INS1049LXL | In distribution | |
| INS1056BLK2XL | In distribution | |
| INS1047BLKS | In distribution | |
| INS1048BLKS | In distribution | |
| INS1047BLUS | In distribution | |
| INS1056BLKS | In distribution | |
| INS1023PNKXXS | In distribution | |
| INS1023BLUXS | In distribution | |
| INS1047BLUL | In distribution | |
| INS1023BLUXXS | In distribution | |
| INS1047BLKXL | In distribution | |
| INS1046S | In distribution | |
| INS1048BLKM | In distribution | |
| INS1046M | In distribution | |
| INS1023PNKXS | In distribution | |
| INS1046L | In distribution | |
| INS1056BLKL | In distribution | |
| INS1047BLUXL | In distribution | |
| INS1047BLUM | In distribution | |
| INS1056BLKXL | In distribution | |
| INS1049SM | In distribution | |
| INS1049 | In distribution | |
| INS1047BLKL | In distribution | |
| INS1009 | In distribution | |
| INS1056BLKM | In distribution | |
| INS1047BLKM | In distribution | |
| INS1057DBLUXXS | In distribution | |
| INS10564XL | In distribution | |
| INS1048BLKL | In distribution | |
| INS1056BLK3XL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Estcarbon | Erismet OU | 172 |
| Relief+ | Solo Laboratories | 36 |
| Hapad Comf-Orthotic Wool Felt Full Length Insole | Hapad, Inc | 22 |
| Hapad Comf-Orthotic 3/4 Length Wool Felt Insole | Hapad, Inc | 21 |
| Hapad Comf-Orthotic Extra Cushioning Insoles | Hapad, Inc | 20 |
| Hapad Comf-Orthotic PRO Blue Insoles | Hapad, Inc | 16 |
| Hapad Heel Lifts | Hapad, Inc | 15 |
| Donjoy Performance | DJO, LLC | 14 |
| Comforsil | Prim,s.a. | 13 |
| Procare | DJO, LLC | 12 |
| 2 Pack Accommodator Semi Rigid PRO FL | Alimed, LLC | 11 |
| Accommodator Semi Rigid PRO FL | Alimed, LLC | 11 |
Showing 12 of 141. All products under Insoles, Medical
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.