Scout
Scout Foot, Right, Caucasian, Midnight Black Housing, 17cm, Category 3
14manufacturers in China registered for this device type
257catalogue numbers in this listing
1recall
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 | College Park Industries, United States |
|---|---|
| FDA product code | ISH |
| Device type | Component, External, Limb, Ankle/Foot |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TA SP | In distribution | |
| SC LTM 17 D1 | In distribution | |
| SC RCM 17 D3 | In distribution | |
| SC RM 21 D2 | In distribution | |
| SC LCM 18 D2 | In distribution | |
| SC LCM 20 D2 | In distribution | |
| SC RM 19 D1 | In distribution | |
| SC RCM 19 D3 | In distribution | |
| SC RBM 18 D3 | In distribution | |
| SC LM 22 D1 | In distribution | |
| SC XBKR 1618 | In distribution | |
| SC RTM 21 D1 | In distribution | |
| SC LTM 15 D1 | In distribution | |
| SC RM 20 D4 | In distribution | |
| SC LM 20 D3 | In distribution | |
| SC LM 19 D4 | In distribution | |
| SC LBM 16 D3 | In distribution | |
| SC GKRB 1618 | In distribution | |
| SC RBM 17 D1 | In distribution | |
| SC LM 22 D3 | In distribution | |
| SC LBM 20 D2 | In distribution | |
| SC RM 20 D2 | In distribution | |
| SC SH 8X25 | In distribution | |
| SC LBM 21 D3 | In distribution | |
| SC LBM 18 D2 | In distribution | |
| SC RBM 19 D4 | In distribution | |
| SC RBM 14 D1 | In distribution | |
| SC LM 17 D2 | In distribution | |
| SC GKRC 1922 | In distribution | |
| SC LTM 21 D3 | In distribution | |
| SC SH 8X10 | In distribution | |
| SC LCM 19 D4 | In distribution | |
| SC RCM 21 D1 | In distribution | |
| SC LCM 20 D3 | In distribution | |
| SC RTM 18 D3 | In distribution | |
| SC LM 16 D2 | In distribution | |
| SC LBM 13 D1 | In distribution | |
| SC RBM 16 D2 | In distribution | |
| SC RTM 22 D4 | In distribution | |
| SC RM 17 D2 | In distribution | |
| SC LBM 21 D4 | In distribution | |
| SC LCM 22 D2 | In distribution | |
| SC LM 20 D4 | In distribution | |
| SC GKRC 1618 | In distribution | |
| SC RM 19 D4 | In distribution | |
| SC LCM 17 D1 | In distribution | |
| SC RCM 18 D2 | In distribution | |
| SC RTM 17 D1 | In distribution | |
| SC SH 8X22 | In distribution | |
| SC RCM 16 D2 | In distribution | |
| SC LBM 20 D4 | In distribution | |
| SC LCM 17 D2 | In distribution | |
| SC RBM 22 D2 | In distribution | |
| SC RBM 22 D3 | In distribution | |
| SC RTM 17 D2 | In distribution | |
| SC LTM 16 D1 | In distribution | |
| SC RTM 18 D1 | In distribution | |
| SC RCM 17 D2 | In distribution | |
| SC RTM 19 D4 | In distribution | |
| SC RTM 19 D1 | In distribution | |
| SC RM 16 D3 | In distribution | |
| SC LTM 18 D1 | In distribution | |
| SC LCM 21 D3 | In distribution | |
| SC RM 21 D1 | In distribution | |
| TXA SP | In distribution | |
| SC RBM 19 D2 | In distribution | |
| SC LCM 22 D4 | In distribution | |
| SC XBKL 1618 | In distribution | |
| SC LCM 13 D1 | In distribution | |
| SC LBM 22 D4 | In distribution | |
| SC GKLT 1618 | In distribution | |
| SC LTM 21 D2 | In distribution | |
| SC LM 15 D1 | In distribution | |
| SC LTM 21 D4 | In distribution | |
| SC LM 14 D1 | In distribution | |
| SC LBM 18 D3 | In distribution | |
| SC RCM 21 D3 | In distribution | |
| SC LCM 17 D3 | In distribution | |
| SC LBM 16 D2 | In distribution | |
| SC LBM 16 D1 | In distribution | |
| SC RTM 17 D3 | In distribution | |
| SC RTM 20 D2 | In distribution | |
| SC RTM 22 D2 | In distribution | |
| SC LCM 19 D3 | In distribution | |
| SC LM 21 D2 | In distribution | |
| SC LGP 1322 | In distribution | |
| SC LBM 19 D1 | In distribution | |
| SC LTM 22 D1 | In distribution | |
| SC LBM 22 D3 | In distribution | |
| SC LBM 17 D2 | In distribution | |
| SC LCM 19 D1 | In distribution | |
| SC RTM 14 D1 | In distribution | |
| SC XBKL 1922 | In distribution | |
| SC RBM 15 D1 | In distribution | |
| SC LTM 16 D3 | In distribution | |
| SC RCM 19 D1 | In distribution | |
| SC RCM 15 D1 | In distribution | |
| SC LCM 20 D1 | In distribution | |
| SC RCM 21 D2 | In distribution | |
| SC RCM 22 D3 | In distribution | |
| SC LM 19 D3 | In distribution | |
| SC LBM 14 D1 | In distribution | |
| SC RM 18 D2 | In distribution | |
| SC RTM 16 D3 | In distribution | |
| SC RTM 20 D3 | In distribution | |
| SC RBM 21 D3 | In distribution | |
| SC RM 13 D1 | In distribution | |
| SC LM 16 D3 | In distribution | |
| SC LTM 20 D3 | In distribution | |
| SC RTM 21 D4 | In distribution | |
| SC LBM 20 D3 | In distribution | |
| SC RBM 20 D2 | In distribution | |
| SC RTM 13 D1 | In distribution | |
| SC LCM 18 D3 | In distribution | |
| SC LBM 19 D3 | In distribution | |
| SC RCM 14 D1 | In distribution | |
| SC LBM 22 D1 | In distribution | |
| SC LM 19 D1 | In distribution | |
| SC RCM 16 D1 | In distribution | |
| SC RM 22 D2 | In distribution | |
| SC LCM 20 D4 | In distribution | |
| SC SH 8X18 | In distribution | |
| SC LTM 19 D4 | In distribution | |
| SC GKLC 1618 | In distribution | |
| SC RBM 19 D1 | In distribution | |
| SC RBM 20 D4 | In distribution | |
| SC LM 22 D2 | In distribution | |
| SC RTM 22 D3 | In distribution | |
| SC LBM 17 D3 | In distribution | |
| SC LTM 19 D2 | In distribution | |
| SC LCM 21 D2 | In distribution | |
| SC GKRT 1618 | In distribution | |
| SC GKRB 1922 | In distribution | |
| SC LTM 17 D2 | In distribution | |
| SC TLGP 1322 | In distribution | |
| SC LM 22 D4 | In distribution | |
| SC RBM 16 D3 | In distribution | |
| SC LCM 14 D1 | In distribution | |
| SC RBM 22 D1 | In distribution | |
| SC LM 17 D1 | In distribution | |
| SC LBM 21 D1 | In distribution | |
| SC RM 17 D3 | In distribution | |
| SC LCM 16 D3 | In distribution | |
| SC LBM 18 D1 | In distribution | |
| SC LBM 15 D1 | In distribution | |
| SC GKLB 1922 | In distribution | |
| SC LTM 21 D1 | In distribution | |
| SC LTM 20 D4 | In distribution | |
| SC RBM 18 D1 | In distribution | |
| SC LTM 19 D1 | In distribution | |
| SC LM 21 D4 | In distribution | |
| SC RTM 16 D1 | In distribution | |
| SC RCM 20 D4 | In distribution | |
| SC LCM 16 D1 | In distribution | |
| TLAM SP | In distribution | |
| SC LTM 14 D1 | In distribution | |
| SC LCM 21 D1 | In distribution | |
| SC RCM 16 D3 | In distribution | |
| SC RTM 16 D2 | In distribution | |
| SC RM 22 D4 | In distribution | |
| SC LCM 22 D3 | In distribution | |
| SC XBKR 1922 | In distribution | |
| SC RTM 19 D2 | In distribution | |
| SC LTM 22 D4 | In distribution | |
| SC LM 18 D3 | In distribution | |
| SC GKLB 1618 | In distribution | |
| SC RTM 20 D1 | In distribution | |
| SC LTM 18 D2 | In distribution | |
| SC RM 14 D1 | In distribution | |
| SC RTM 18 D2 | In distribution | |
| SC RBM 18 D2 | In distribution | |
| TLAL SP | In distribution | |
| SC LCM 21 D4 | In distribution | |
| SC RCM 21 D4 | In distribution | |
| SC RCM 19 D2 | In distribution | |
| SC RBM 17 D3 | In distribution | |
| SC RM 22 D3 | In distribution | |
| SC HWK 1315 | In distribution | |
| SC GKRT 1922 | In distribution | |
| SC RM 19 D3 | In distribution | |
| SC LBM 20 D1 | In distribution | |
| SC GKLT 1922 | In distribution | |
| SC RBM 19 D3 | In distribution | |
| SC RTM 20 D4 | In distribution | |
| SC RBM 17 D2 | In distribution | |
| SC RBM 21 D1 | In distribution | |
| SC RM 16 D1 | In distribution | |
| SC LCM 16 D2 | In distribution | |
| SC RCM 18 D3 | In distribution | |
| SC RM 21 D4 | In distribution | |
| SC RCM 22 D4 | In distribution | |
| SC RTM 19 D3 | In distribution | |
| SC LTM 16 D2 | In distribution | |
| SC LCM 18 D1 | In distribution | |
| SC RBM 21 D4 | In distribution | |
| SC LCM 15 D1 | In distribution | |
| SC LM 21 D3 | In distribution | |
| SC RCM 17 D1 | In distribution | |
| SC LM 17 D3 | In distribution | |
| SC LA FAB | In distribution | |
| SC RM 17 D1 | In distribution | |
| SC LBM 22 D2 | In distribution | |
| SC HWK 1618 | In distribution | |
| SC LCM 22 D1 | In distribution | |
| SC RM 20 D3 | In distribution | |
| SC LM 16 D1 | In distribution | |
| SC RM 18 D1 | In distribution | |
| SC LM 20 D1 | In distribution | |
| SC RTM 21 D2 | In distribution | |
| SC LTM 20 D2 | In distribution | |
| SC RM 18 D3 | In distribution | |
| SC RM 22 D1 | In distribution | |
| SC LBM 21 D2 | In distribution | |
| SC RBM 22 D4 | In distribution | |
| SC RCM 20 D2 | In distribution | |
| SC LM 21 D1 | In distribution | |
| SC LTM 20 D1 | In distribution | |
| SC RCM 22 D2 | In distribution | |
| SC LTM 13 D1 | In distribution | |
| SC LM 13 D1 | In distribution | |
| TLAS SP | In distribution | |
| SC RCM 20 D3 | In distribution | |
| SC LCM 19 D2 | In distribution | |
| SC LTM 18 D3 | In distribution | |
| SC RCM 22 D1 | In distribution | |
| SC RTM 22 D1 | In distribution | |
| SC RBM 20 D3 | In distribution | |
| SC HWK 1922 | In distribution | |
| SC RTM 21 D3 | In distribution | |
| SC RBM 20 D1 | In distribution | |
| SC RCM 18 D1 | In distribution | |
| SC RM 20 D1 | In distribution | |
| SC RM 15 D1 | In distribution | |
| SC LTM 22 D2 | In distribution | |
| SC LM 19 D2 | In distribution | |
| SC LTM 17 D3 | In distribution | |
| SC RTM 15 D1 | In distribution | |
| SC RBM 13 D1 | In distribution | |
| SC LAGK | In distribution | |
| SC RBM 21 D2 | In distribution | |
| TR SP | In distribution | |
| SC RM 19 D2 | In distribution | |
| SC LTM 22 D3 | In distribution | |
| SC LM 18 D2 | In distribution | |
| SC RBM 16 D1 | In distribution | |
| SC LM 18 D1 | In distribution | |
| SC LBM 17 D1 | In distribution | |
| SC RCM 20 D1 | In distribution | |
| SC RM 21 D3 | In distribution | |
| SC LM 20 D2 | In distribution |
Showing 250 of 257 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 |
| Trulife | Trulife, Inc. | 1,309 |
| 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 |
Showing 12 of 39. All products under Component, External, Limb, Ankle/Foot
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-04-05 | Not classified | Mixed-up of materials/components | An incorrect shorter part ( pyramid) was installed in the foot. A foot of this size and configuration requires a longer pyramid. Customers requiring the extra firm configuration may have a minimal risk of component failure, which could be | 11 | 2012-07-31 |
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.