Lafayette Hand-Held Dynamometer
The Lafayette Hand-Held Dynamometer is an ergonomic hand-held device for objectively quantifying muscle strength. The device comes in an ergonomic plastic housing that fits comfortably in…
The Lafayette Hand-Held Dynamometer is an ergonomic hand-held device for objectively quantifying muscle strength. The device comes in an ergonomic plastic housing that fits comfortably in the palm of the hand. An elastic strap helps keep the HHD in place. The device has a LCD screen for data readout and menus for setup. The patient pushes on a stirrup accessory which is attached to the shaft of a force measuring load cell. The load cell senses the amount of force being applied to the device by the patient and this load is displayed in the LCD in pounds, kilograms or newtons. An optional test stand accessory and holder are used to position the HHD for the test.
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Suga Technology (Dongguan) Co.. Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Shenzhen Visbody Intelligent Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
| Forethought(Shanghai)Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
Record
| Listed by | Lafayette Instrument Co., Inc., United States |
|---|---|
| FDA product code | KQX |
| Device type | Goniometer, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 888.1500 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-08-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 40 to 95 °F; Handling environment temperature 40 to 95 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01165 | In distribution | |
| 01165A | In distribution |
Same Product Code
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| Ultium | Noraxon U.S.A., Inc. | 16 |
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| e-vive Nmes System | Motive Health, Inc. | 9 |
| e-vive Nmes System with Post-Op Brace; Small/Medium, Left (2.0 Dock) | Motive Health, Inc. | 6 |
| myoMOTION | Noraxon U.S.A., Inc. | 5 |
| Digital Knee® | Opum Technologies Services | 3 |
| MyNotifi Rx | Medhab, LLC | 3 |
| e-vive Nmes System with Post-Op Brace; Large/XL, Left | Motive Health, Inc. | 3 |
| e-vive Nmes System with Post-Op Brace; Large/XL, Right | Motive Health, Inc. | 3 |
| e-vive Nmes System with Post-Op Brace; 2XL/3XL, Left (2.0 Dock) | Motive Health, Inc. | 3 |
| e-vive Nmes System with Post-Op Brace; 2XL/3XL, Right (2.0 Dock) | Motive Health, Inc. | 3 |
| MyoVision Software | Precision Biometrics, Inc. | 3 |
Showing 12 of 111. All products under Goniometer, Ac-Powered
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.