Relief+
Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare approved inserts. The Relief and Relief+ Custom Orthotic are indicated for Type I Diabetics and…
Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare approved inserts. The Relief and Relief+ Custom Orthotic are indicated for Type I Diabetics and Type II Diabetics with pre-ulcerative calluses, poor circulation, diabetics ulcers, previous amputations or partial amputation of either foot.
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 | Solo Laboratories, United States |
|---|---|
| FDA product code | KYS |
| Device type | Insoles, Medical |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6280 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Insole with Plastizote cover, right (3) | In distribution | |
| Insole with Plastizote cover, pair | In distribution | |
| Insole with Pcell cover, right | In distribution | |
| Insole with Pcell cover, right (2) | In distribution | |
| Insole with Plastizote cover, 3 pair | In distribution | |
| Insole with Pcell cover, left (2) | In distribution | |
| Insole with Plastizote cover, 3 pair | In distribution | |
| Insole with Plastizote cover, right (2) | In distribution | |
| Insole with Pcell cover, left (3) | In distribution | |
| Insole with Plastizote cover, right | In distribution | |
| Insole with Pcell cover, right (3) | In distribution | |
| Insole with Pcell cover, 3 pair | In distribution | |
| Insole with Pcell cover, right (2) | In distribution | |
| Insole with Pcell cover, left | In distribution | |
| Insole with Plastizote cover, left (2) | In distribution | |
| Insole with Plastizote cover, right (2) | In distribution | |
| Insole with Plastizote cover, right (3) | In distribution | |
| Insole with Plastizote cover, left | In distribution | |
| Insole with Plastizote cover, 2 pair | In distribution | |
| Insole with Pcell cover, 2 pair | In distribution | |
| Insole with Pcell cover, pair | In distribution | |
| Insole with Pcell cover, pair | In distribution | |
| Insole with Plastizote cover, left | In distribution | |
| Insole with Pcell cover, left (3) | In distribution | |
| Insole with Plastizote cover, left (3) | In distribution | |
| Insole with Plastizote cover, 2 pair | In distribution | |
| Insole with Pcell cover, 3 pair | In distribution | |
| Insole with Pcell cover, 2 pair | In distribution | |
| Insole with Plastizote cover, right | In distribution | |
| Insole with Pcell cover, left (2) | In distribution | |
| Insole with Pcell cover, right (3) | In distribution | |
| Insole with Plastizote cover, pair | In distribution | |
| Insole with Plastizote cover, left (3) | In distribution | |
| Insole with Pcell cover, right | In distribution | |
| Insole with Pcell cover, left | In distribution | |
| Insole with Plastizote cover, left (2) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Estcarbon | Erismet OU | 172 |
| ViveSole | Vive Health LLC | 31 |
| 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.