Trulife
Trulife Zenith LP Foot 27CM Right CAT 3 DK BRN
14manufacturers in China registered for this device type
1,309catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Anhui (3), Fujian (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hefei Mlush Sanitary Products Co., Ltd. | Hefei | Anhui | Manufacturer | 48 |
| Orthotech Rehabilitation Co., Ltd. | Xiamen | Fujian | Manufacturer | 26 |
| Medex Medical Supplies Ltd. | China | Guangdong | Contract manufacturer | 20 |
| Kaipeng Medical Tech Development Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 12 |
| Huae Trade Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 10 |
| Baoji Shengtaike Industry & Trade Co., Ltd. | Baoji | Shanxi | Contract manufacturer | 7 |
Showing 12 of 14. All 14 manufacturers in China registered for Component, External, Limb, Ankle/Foot
Record
| Listed by | Trulife, Inc., United States |
|---|---|
| FDA product code | ISH |
| Device type | Component, External, Limb, Ankle/Foot |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-31 |
| Record revised | 2025-09-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SEF190-22-R-2S2 | In distribution | |
| SEC211-26R | In distribution | |
| SLF198-23-L-H5 | In distribution | |
| SEF132-20-L-3L0 | In distribution | |
| SLS493-24-R-3 | In distribution | |
| SLF198-24-R-H6 | In distribution | |
| SKF100-24-R-4B4 | In distribution | |
| SSF400-22-L-1 | In distribution | |
| SKF110-25-L-3B5 | In distribution | |
| SKF103-28-L-5B8 | In distribution | |
| SZN200-26-L-3 | In distribution | |
| SZN103-27-R-3 | In distribution | |
| SLF195-28-L-H7 | In distribution | |
| AAA223 | In distribution | |
| SCA237-01 | In distribution | |
| SKF110-25-L-2A5 | In distribution | |
| SEF193-25-R-3M5 | In distribution | |
| SKF113-28-L-4B8 | In distribution | |
| SEF132-18-L-3M8 | In distribution | |
| SEF144-13-L-1S3 | In distribution | |
| SEC211-27L | In distribution | |
| SKF-REFURB-KIT-01 | In distribution | |
| SKF203-29-L-4 | In distribution | |
| SFC193-25-L-K12 | In distribution | |
| SSF400-29-R-3 | In distribution | |
| SLF198-29-L-H8 | In distribution | |
| SFC293-24-R-DKB | In distribution | |
| SKF203-24-L-3 | In distribution | |
| SFC190-24-L-K12 | In distribution | |
| SFC290-25-L-CAU | In distribution | |
| SZN203-30-R-3 | In distribution | |
| SEF144-17-R-3M7 | In distribution | |
| SFC290-30-L-CAU | In distribution | |
| SEF190-24-L-2S4 | In distribution | |
| SEF132-13-L-3S3 | In distribution | |
| SEF132-19-L-6L9 | In distribution | |
| SLS493-29-R-3 | In distribution | |
| SFS242 | In distribution | |
| SZN103-28-R-1 | In distribution | |
| SKF103-25-R-3B5 | In distribution | |
| SLF195-27-L-H5 | In distribution | |
| SEF132-20-L-5L0 | In distribution | |
| SZN103-24-R-1 | In distribution | |
| SLS493-29-L-4 | In distribution | |
| SZN103-24-L-1 | In distribution | |
| SZN100-25-L-3 | In distribution | |
| SFC293-23-L-DKB | In distribution | |
| SNF160-27L | In distribution | |
| SZN100-24-L-1 | In distribution | |
| SLF198-23-L-H6 | In distribution | |
| SZM450-29-L | In distribution | |
| SZN100-27-L-2 | In distribution | |
| SLS493-25-L-3 | In distribution | |
| SKF200-27-L-2 | In distribution | |
| SLF195-23-R-H8 | In distribution | |
| SCH113-22R | In distribution | |
| SFC293-26-R-DKB | In distribution | |
| SEF193-26-L-4M6 | In distribution | |
| SSF400-24-R-3 | In distribution | |
| SLF198-27-L-H8 | In distribution | |
| SZN103-25-L-2 | In distribution | |
| SKF113-26-L-4B6 | In distribution | |
| SCH113-22L | In distribution | |
| SLS493-28-R-2 | In distribution | |
| SSF403-28-R-1 | In distribution | |
| SEF144-21-L-6L1 | In distribution | |
| SLS493-28-L-4 | In distribution | |
| SZN200-24-L-1 | In distribution | |
| SEF190-27-L-2M7 | In distribution | |
| SKF103-27-L-3B7 | In distribution | |
| SEF193-23-L-2S3 | In distribution | |
| SEF132-21-R-3L1 | In distribution | |
| SZM453-25-R | In distribution | |
| SLS490-29-R-4 | In distribution | |
| SKF110-28-R-4B8 | In distribution | |
| SLF198-26-L-H8 | In distribution | |
| SEF144-20-L-5L0 | In distribution | |
| SLF198-26-L-H7 | In distribution | |
| SKF100-26-L-5B6 | In distribution | |
| SFC293-28-R-DKB | In distribution | |
| SKF203-26-R-3 | In distribution | |
| SCH110-25L | In distribution | |
| SKF100-26-R-2A6 | In distribution | |
| SZN103-23-R-2 | In distribution | |
| SKF200-25-L-3 | In distribution | |
| AAAK100 | In distribution | |
| SZN200-28-L-3 | In distribution | |
| SLS493-26-L-1 | In distribution | |
| SSF400-29-L-3 | In distribution | |
| SEF190-22-L-1S2 | In distribution | |
| SLF195-22-R-H5 | In distribution | |
| SZN203-24-L-1 | In distribution | |
| SLF198-27-R-H8 | In distribution | |
| SLF198-25-L-H8 | In distribution | |
| SZN100-30-R-3 | In distribution | |
| SLS493-22-R-1 | In distribution | |
| SFC190-27-L-K34 | In distribution | |
| SZN200-30-R-3 | In distribution | |
| SFC290-27-L-CAU | In distribution | |
| SEF193-27-R-2M7 | In distribution | |
| SEF193-23-R-1S3 | In distribution | |
| SZM450-30-L | In distribution | |
| SLF198-29-L-H7 | In distribution | |
| SKF100-29-L-5B9 | In distribution | |
| SKF113-28-R-3B8 | In distribution | |
| SZN100-26-L-2 | In distribution | |
| SEF193-26-L-1M6 | In distribution | |
| SKF103-27-L-5B7 | In distribution | |
| AAA135 | In distribution | |
| SKF200-26-R-5 | In distribution | |
| SLF195-28-L-H6 | In distribution | |
| SZN103-26-L-3 | In distribution | |
| SKF100-27-R-3B7 | In distribution | |
| SLF198-24-R-H9 | In distribution | |
| SLC303 | In distribution | |
| SKF113-26-L-3B6 | In distribution | |
| SZM453-28-R | In distribution | |
| SAB320 | In distribution | |
| SFC190-22-L-K12 | In distribution | |
| SCH113-27L | In distribution | |
| SLF198-26-R-H7 | In distribution | |
| SFB546 | In distribution | |
| SNF163-28R | In distribution | |
| SKF110-26-R-3B6 | In distribution | |
| SKF103-26-R-3B6 | In distribution | |
| SKF200-29-R-4 | In distribution | |
| SLS490-26-L-1 | In distribution | |
| SKF200-23-R-1 | In distribution | |
| SCH110-24L | In distribution | |
| SLF198-28-L-H7 | In distribution | |
| SKF110-28-L-2A8 | In distribution | |
| SLS490-29-L-4 | In distribution | |
| SFS232 | In distribution | |
| SKF103-26-L-3B6 | In distribution | |
| SLS493-25-L-2 | In distribution | |
| SEF193-25-L-2M5 | In distribution | |
| SFC190-29-R-K12 | In distribution | |
| SKF110-22-L-1A2 | In distribution | |
| SKF200-29-L-4 | In distribution | |
| SCH110-22L | In distribution | |
| SZN103-30-L-3 | In distribution | |
| SEF190-27-R-4M7 | In distribution | |
| SEF193-29-R-4L9 | In distribution | |
| SKF110-24-R-2A4 | In distribution | |
| SLF198-23-R-H5 | In distribution | |
| SKF200-26-R-4 | In distribution | |
| AEV350 | In distribution | |
| SZN200-25-R-3 | In distribution | |
| SEF132-16-L-2M6 | In distribution | |
| SKF113-30-L-5B0 | In distribution | |
| SZN200-26-L-1 | In distribution | |
| SZN200-28-R-1 | In distribution | |
| SSF403-24-L-2 | In distribution | |
| SFC193-27-L-K12 | In distribution | |
| SEF132-17-R-4M7 | In distribution | |
| AAA222 | In distribution | |
| SSF400-27-R-3 | In distribution | |
| AAAK285 | In distribution | |
| SZN103-24-R-2 | In distribution | |
| SKF110-26-R-2A6 | In distribution | |
| SLF195-24-R-H7 | In distribution | |
| SEF144-20-R-3L0 | In distribution | |
| SKF103-26-L-5B6 | In distribution | |
| SKF200-25-R-2 | In distribution | |
| SLF195-24-L-H5 | In distribution | |
| SEF190-27-R-3M7 | In distribution | |
| SKF113-23-L-1A3 | In distribution | |
| SSF400-25-R-3 | In distribution | |
| SFC290-26-L-CAU | In distribution | |
| SCH110-29R | In distribution | |
| AAA210 | In distribution | |
| SLS490-23-L-2 | In distribution | |
| SFC193-25-R-K34 | In distribution | |
| SKF103-27-R-3B7 | In distribution | |
| SZN200-24-R-3 | In distribution | |
| SEF144-21-R-4L1 | In distribution | |
| SEF190-25-R-2M5 | In distribution | |
| SKF110-29-R-4B9 | In distribution | |
| SEF193-23-L-1S3 | In distribution | |
| SKF100-29-L-3B9 | In distribution | |
| SEC210-23L | In distribution | |
| SEF193-24-R-2S4 | In distribution | |
| SFC293-24-L-DKB | In distribution | |
| SKF203-27-L-3 | In distribution | |
| SSF400-23-L-2 | In distribution | |
| SLF198-25-R-H9 | In distribution | |
| SZN200-27-L-2 | In distribution | |
| SEF132-19-L-4L9 | In distribution | |
| SKF200-24-R-4 | In distribution | |
| SKF100-26-L-2A6 | In distribution | |
| SKF203-26-R-4 | In distribution | |
| SKF110-24-L-3B4 | In distribution | |
| SEF190-27-R-1M7 | In distribution | |
| SZN103-22-R-1 | In distribution | |
| SFS245 | In distribution | |
| SKF-KIT | In distribution | |
| SEF193-28-R-2L8 | In distribution | |
| SKF103-24-R-2A4 | In distribution | |
| SKF113-27-L-3B7 | In distribution | |
| SEF190-25-R-3M5 | In distribution | |
| SKF100-30-R-5B0 | In distribution | |
| SCH110-23R | In distribution | |
| SKF200-24-L-4 | In distribution | |
| SLF198-22-L-H6 | In distribution | |
| SLS490-24-L-2 | In distribution | |
| SSF400-26-R-1 | In distribution | |
| AAAK135 | In distribution | |
| SKF103-24-R-4B4 | In distribution | |
| SLF195-27-L-H7 | In distribution | |
| SLF198-24-R-H8 | In distribution | |
| SLS490-28-L-4 | In distribution | |
| SFC293-30-R-DKB | In distribution | |
| SKF-BMP-4 | In distribution | |
| SLS490-26-L-3 | In distribution | |
| SEF144-17-R-2M7 | In distribution | |
| SEC210-24L | In distribution | |
| SKF203-27-R-2 | In distribution | |
| SEC210-25R | In distribution | |
| SSF403-22-R-1 | In distribution | |
| AAA224 | In distribution | |
| SZN103-25-R-1 | In distribution | |
| SLF195-26-R-H5 | In distribution | |
| SLF195-26-R-H8 | In distribution | |
| SKF103-28-R-2A8 | In distribution | |
| SZN200-28-R-3 | In distribution | |
| SEF144-19-L-5L9 | In distribution | |
| SSF400-26-L-2 | In distribution | |
| SKF110-29-L-5B9 | In distribution | |
| SKF113-24-L-2A4 | In distribution | |
| SKF100-28-R-2A8 | In distribution | |
| SCH110-22R | In distribution | |
| SEC201-24R | In distribution | |
| SKF103-25-L-4B5 | In distribution | |
| SLF198-25-R-H5 | In distribution | |
| SEF193-27-L-1M7 | In distribution | |
| SKF113-28-R-2A8 | In distribution | |
| SLF195-25-R-H7 | In distribution | |
| SKF110-27-L-3B7 | In distribution | |
| SNF163-28L | In distribution | |
| SLF198-22-R-H7 | In distribution | |
| SEF132-19-R-4L9 | In distribution | |
| SEF144-17-L-2M7 | In distribution | |
| SZM453-25-L | In distribution | |
| SEF144-20-L-4L0 | In distribution | |
| SSF403-27-R-2 | In distribution | |
| SKF203-30-L-5 | In distribution | |
| SLF195-27-L-H8 | In distribution | |
| SAB310 | In distribution | |
| SFC190-26-R-K12 | In distribution | |
| SZN203-25-L-1 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Soleus | College Park Industries | 6,180 |
| Onyx | College Park Industries | 3,048 |
| TruStep | College Park Industries | 2,635 |
| Venture | College Park Industries | 1,560 |
| Accent | College Park Industries | 1,152 |
| Tribute | College Park Industries | 904 |
| Velocity | College Park Industries | 648 |
| Terrain | College Park Industries | 585 |
| Hoizon HD | College Park Industries | 585 |
| Orbit | College Park Industries | 540 |
| Odyssey K3 | College Park Industries | 450 |
| Aviator | College Park Industries | 405 |
Showing 12 of 39. All products under Component, External, Limb, Ankle/Foot
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.