Duns Number:005080650
Device Description: The Lafayette Hand-Held Dynamometer is an ergonomic hand-held device for objectively quant 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.
Catalog Number
01165
Brand Name
Lafayette Hand-Held Dynamometer
Version/Model Number
01165
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KQX
Product Code Name
Goniometer, Ac-Powered
Public Device Record Key
7d1cf414-8b22-4cc4-a390-12b9b54f6948
Public Version Date
September 08, 2021
Public Version Number
1
DI Record Publish Date
August 31, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 21 |