Physical Medicine › ProstheticComponent, External, Limb, Ankle/Foot

Tempo

Tempo Foot, Right, Caucasian, Endo IP, 23cm, Category 2

Registry build 21.09.26
14manufacturers in China registered for this device type
276catalogue 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.

Chinese manufacturers registered for FDA product code ISH
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

Regulatory record for Tempo
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 2023-07-10

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Tempo
Catalogue number Size Status
TO LTEN 22 D3 In distribution
TO RTEN 25 D5 In distribution
TO LCEN 29 D2 In distribution
TO RBEN 28 D4 In distribution
TO RCEN 23 D2 In distribution
TO LCEN 28 D1 In distribution
TO LBEN 22 D3 In distribution
TO RCEN 21 D1 In distribution
TO RBEN 23 D1 In distribution
TO LCEN 24 D4 In distribution
TO RBEN 29 D2 In distribution
TO LTEN 28 D3 In distribution
TO RCEN 27 D3 In distribution
TO RCEN 29 D2 In distribution
TO LCEN 30 D5 In distribution
TO RCEN 25 D2 In distribution
TO LCEN 26 D5 In distribution
TO RTEN 29 D3 In distribution
TO RCEN 22 D3 In distribution
TO RTEN 24 D3 In distribution
TO RBEN 30 D1 In distribution
TO LTEN 25 D4 In distribution
TO RBEN 25 D5 In distribution
TO RCEN 29 D4 In distribution
TO LCEN 25 D2 In distribution
TO RTEN 28 D1 In distribution
TO LBEN 23 D2 In distribution
TO LTEN 22 D4 In distribution
TO RBEN 22 D3 In distribution
TO LTEN 29 D1 In distribution
TO LTEN 27 D2 In distribution
TO RBEN 21 D1 In distribution
TO LBEN 29 D2 In distribution
TO LTEN 24 D1 In distribution
TO LBEN 24 D1 In distribution
TO LTEN 23 D2 In distribution
TO RBEN 24 D1 In distribution
TO LCEN 24 D1 In distribution
TO LCEN 30 D1 In distribution
TO RCEN 22 D4 In distribution
TO LCEN 28 D4 In distribution
TO LBEN 26 D1 In distribution
TO RTEN 30 D3 In distribution
TO LBEN 21 D1 In distribution
TO LCEN 30 D3 In distribution
TO RBEN 26 D5 In distribution
TO RTEN 25 D3 In distribution
TO RBEN 30 D4 In distribution
TO RTEN 25 D1 In distribution
TO LTEN 24 D2 In distribution
TO LBEN 24 D4 In distribution
TO LBEN 27 D3 In distribution
TO RCEN 28 D4 In distribution
TO LTEN 30 D5 In distribution
TO LBEN 25 D2 In distribution
TO LBEN 27 D2 In distribution
TO LTEN 26 D4 In distribution
TO RCEN 26 D1 In distribution
TO LCEN 26 D4 In distribution
TO RBEN 21 D3 In distribution
TO RCEN 30 D5 In distribution
TO LBEN 25 D5 In distribution
TO RBEN 28 D1 In distribution
TO RCEN 23 D1 In distribution
TO LBEN 23 D1 In distribution
TO LBEN 30 D1 In distribution
TO RTEN 29 D4 In distribution
TO LBEN 26 D2 In distribution
TO LCEN 26 D1 In distribution
TO LCEN 26 D2 In distribution
TO RBEN 26 D4 In distribution
TO RTEN 23 D4 In distribution
TO LCEN 21 D1 In distribution
TO RTEN 29 D1 In distribution
TO RCEN 26 D4 In distribution
TO LTEN 27 D1 In distribution
TO RBEN 22 D1 In distribution
TO LTEN 28 D5 In distribution
TO LBEN 26 D5 In distribution
TO LTEN 25 D3 In distribution
TO RBEN 23 D3 In distribution
TO RBEN 28 D5 In distribution
TO RBEN 29 D4 In distribution
TO RCEN 22 D1 In distribution
TO RTEN 27 D3 In distribution
TO RBEN 23 D2 In distribution
TO LCEN 23 D2 In distribution
TO RBEN 27 D2 In distribution
TO LTEN 21 D2 In distribution
TO LCEN 25 D3 In distribution
TO LBEN 29 D1 In distribution
TO LTEN 29 D3 In distribution
TO LTEN 27 D4 In distribution
TO RTEN 23 D2 In distribution
TO RTEN 24 D1 In distribution
TO RTEN 25 D4 In distribution
TO LTEN 25 D1 In distribution
TO RTEN 27 D2 In distribution
TO RTEN 26 D4 In distribution
TO RBEN 27 D1 In distribution
TO LBEN 27 D4 In distribution
TO LBEN 27 D1 In distribution
TO RCEN 27 D4 In distribution
TO LBEN 21 D4 In distribution
TO RBEN 30 D3 In distribution
TO LCEN 23 D3 In distribution
TO LTEN 30 D3 In distribution
TO LBEN 21 D3 In distribution
TO RCEN 27 D5 In distribution
TO RBEN 21 D2 In distribution
TO RCEN 23 D3 In distribution
TO RCEN 30 D4 In distribution
TO LTEN 24 D4 In distribution
TO RCEN 24 D1 In distribution
TO LTEN 24 D3 In distribution
TO LCEN 25 D4 In distribution
TO RTEN 21 D4 In distribution
TO LCEN 30 D2 In distribution
TO RTEN 22 D1 In distribution
TO RCEN 26 D3 In distribution
TO LCEN 25 D1 In distribution
TO LBEN 26 D4 In distribution
TO LTEN 30 D4 In distribution
TO RTEN 26 D2 In distribution
TO LBEN 29 D3 In distribution
TO RCEN 30 D1 In distribution
TO LCEN 25 D5 In distribution
TO LBEN 28 D5 In distribution
TO RTEN 22 D4 In distribution
TO RCEN 30 D2 In distribution
TO LBEN 28 D4 In distribution
TO LBEN 30 D2 In distribution
TO LTEN 29 D4 In distribution
TO LCEN 22 D3 In distribution
TO LBEN 30 D4 In distribution
TO RTEN 28 D3 In distribution
TO RTEN 27 D4 In distribution
TO RCEN 29 D1 In distribution
TO LBEN 25 D4 In distribution
TO LBEN 24 D3 In distribution
TO RCEN 21 D4 In distribution
TO LTEN 22 D1 In distribution
TO RTEN 28 D4 In distribution
TO RCEN 25 D5 In distribution
TO RCEN 28 D2 In distribution
TO RCEN 30 D3 In distribution
TO LTEN 30 D2 In distribution
TO LBEN 27 D5 In distribution
TO RCEN 24 D4 In distribution
TO RTEN 25 D2 In distribution
TO RTEN 26 D5 In distribution
TO RCEN 28 D3 In distribution
TO RBEN 29 D3 In distribution
TO LCEN 29 D3 In distribution
TO LBEN 23 D3 In distribution
TO LCEN 23 D1 In distribution
TO RBEN 25 D1 In distribution
TO RBEN 30 D5 In distribution
TO LCEN 27 D4 In distribution
TO LTEN 29 D2 In distribution
TO RTEN 26 D1 In distribution
TO LTEN 26 D3 In distribution
TO LTEN 21 D1 In distribution
TO RCEN 24 D2 In distribution
TO LBEN 29 D4 In distribution
TO LCEN 28 D3 In distribution
TO RTEN 27 D5 In distribution
TO LCEN 24 D2 In distribution
TO RTEN 30 D4 In distribution
TO RTEN 21 D1 In distribution
TO RTEN 23 D1 In distribution
TO RBEN 26 D3 In distribution
TO LTEN 29 D5 In distribution
TO LBEN 30 D3 In distribution
TO LCEN 21 D2 In distribution
TO LBEN 22 D4 In distribution
TO RCEN 28 D5 In distribution
TO LBEN 28 D1 In distribution
TO LCEN 21 D3 In distribution
TO LCEN 26 D3 In distribution
TO RCEN 23 D4 In distribution
TO RTEN 22 D2 In distribution
TO RCEN 22 D2 In distribution
TO LBEN 29 D5 In distribution
TO LCEN 22 D4 In distribution
TO LTEN 27 D3 In distribution
TO RCEN 26 D2 In distribution
TO LTEN 28 D2 In distribution
TO LTEN 27 D5 In distribution
TO RCEN 27 D2 In distribution
TO RTEN 30 D5 In distribution
TO LBEN 21 D2 In distribution
TO LCEN 21 D4 In distribution
TO RTEN 28 D2 In distribution
TO LTEN 21 D4 In distribution
TO LCEN 29 D1 In distribution
TO RBEN 30 D2 In distribution
TO RBEN 24 D2 In distribution
TO LTEN 26 D2 In distribution
TO LTEN 28 D1 In distribution
TO LBEN 25 D1 In distribution
TO RBEN 26 D2 In distribution
TO RBEN 23 D4 In distribution
TO LTEN 22 D2 In distribution
TO RCEN 21 D3 In distribution
TO LTEN 25 D5 In distribution
TO LTEN 25 D2 In distribution
TO LTEN 23 D4 In distribution
TO LTEN 23 D3 In distribution
TO LBEN 28 D2 In distribution
TO RCEN 21 D2 In distribution
TO RTEN 26 D3 In distribution
TO RCEN 25 D4 In distribution
TO RBEN 29 D5 In distribution
TO RBEN 24 D4 In distribution
TO RTEN 22 D3 In distribution
TO RCEN 28 D1 In distribution
TO RBEN 27 D4 In distribution
TO RTEN 23 D3 In distribution
TO RTEN 21 D2 In distribution
TO LCEN 27 D1 In distribution
TO RTEN 21 D3 In distribution
TO LCEN 27 D3 In distribution
TO RTEN 29 D5 In distribution
TO LCEN 22 D2 In distribution
TO RTEN 29 D2 In distribution
TO RTEN 28 D5 In distribution
TO RTEN 30 D1 In distribution
TO RBEN 25 D2 In distribution
TO RTEN 27 D1 In distribution
TO LBEN 26 D3 In distribution
TO LCEN 29 D5 In distribution
TO LTEN 26 D5 In distribution
TO RBEN 29 D1 In distribution
TO RBEN 22 D2 In distribution
TO LBEN 28 D3 In distribution
TO RTEN 24 D2 In distribution
TO RBEN 28 D2 In distribution
TO RCEN 24 D3 In distribution
TO RBEN 27 D3 In distribution
TO RBEN 28 D3 In distribution
TO LBEN 30 D5 In distribution
TO RBEN 25 D3 In distribution
TO LTEN 30 D1 In distribution
TO LCEN 29 D4 In distribution
TO RCEN 27 D1 In distribution
TO LBEN 22 D1 In distribution
TO RCEN 29 D5 In distribution
TO LCEN 24 D3 In distribution
TO LTEN 26 D1 In distribution

Showing 250 of 276 catalogue numbers.

Same Product Code

Other products under the same FDA 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.

Recalls referencing this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer