Apos 4
30 catalogue numbers from APOS 4 BLACK VELCRO HIGH CUT KNIT 35, listed by Apos Medical Assets Ltd, Israel, under Shoe With Adjustable Sole Units. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
30catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wenzhou First Light Industry Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 3 |
| Dongguan Redthera Technology Co., Ltd. | Dongguan | Guangdong | Repacker / relabeller | 22 |
Record
| Listed by | Apos Medical Assets Ltd, Israel |
|---|---|
| FDA product code | QDT |
| Device type | Shoe With Adjustable Sole Units |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Establishment | Manufacturer |
| 510(k) | K182090 |
| Record published | 2022-06-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Master box of 6, box of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| APOS 4 BLACK VELCRO HIGH CUT KNIT 35 | In distribution | |
| APOS 4 GRAY LACE SIZE 36 | In distribution | |
| APOS 4 BLACK VELCRO HIGH CUT KNOT 42 | In distribution | |
| APOS BLACK VELCROHIGH CUT KNIT 37 | In distribution | |
| APOS 4 BLACK VELCRO HIGH CUT KNOT 49 | In distribution | |
| APOS 4 BLACK VELCRO HIGH CUT KNOT 41 | In distribution | |
| APOS 4 GRAY LACE SIZE 47 | In distribution | |
| APOS 4 GRAY LACE SIZE 44 | In distribution | |
| APOS 4 GRAY LACE SIZE 43 | In distribution | |
| APOS 4 GRAY LACE SIZE 39 | In distribution | |
| APOS 4 BLACK VELCRO HIGH CUT KNOT 44 | In distribution | |
| APOS 4 BLACK VELCRO HIGH CUT KNOT 48 | In distribution | |
| APOS 4 BLACK VELCRO HIGH CUT KNOT 46 | In distribution | |
| APOS 4 GRAY LACE SIZE 35 | In distribution | |
| APOS BLACK VELCRO HIGH CUT KNIT 38 | In distribution | |
| APOS 4 GRAY LACE SIZE 45 | In distribution | |
| APOS 4 GRAY LACE SIZE 40 | In distribution | |
| APOS 4 BLACK VELCRO HIGH CUT KNOT 40 | In distribution | |
| APOS 4 GRAY LACE SIZE 41 | In distribution | |
| APOS 4 GRAY LACE SIZE 46 | In distribution | |
| APOS 4 BLACK VELCRO HIGH CUT KNOT 44 | In distribution | |
| APOS BLACK VELCRO HIGH CUT KNIT 39 | In distribution | |
| APOS 4 BLACK VELCRO HIGH CUT KNOT 43 | In distribution | |
| APOS 4 BLACK VELCRO HIGH CUT KNOT 47 | In distribution | |
| APOS 4 GRAY LACE SIZE 42 | In distribution | |
| APOS 4 GRAY LACE SIZE 38 | In distribution | |
| APOS 4 GRAY LACE SIZE 37 | In distribution | |
| APOS 4 GRAY LACE SIZE 49 | In distribution | |
| APOS 4 GRAY LACE SIZE 48 | In distribution | |
| APOS 4 BLACK VELCRO HIGH CUT KNIT 36 | In distribution |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182090 | 2018-11-16 |
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.