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Lafayette Hand-Held Dynamometer

FDA UDI

Class I (US FDA UDI)

by Lafayette Instrument Company

Identity

Trade Name
Lafayette Hand-Held Dynamometer FDA UDI
Generic Name
Back/leg/chest dynamometer, electronic FDA UDI
Device Name
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. FDA UDI
Model / Reference
01165 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
01165 FDA UDI
Primary DI / UDI-DI
00855170007003 FDA UDI
FDA Product Code
KQX FDA UDI
GMDN Term
Back/leg/chest dynamometer, electronic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Back/leg/chest dynamometer, electronic

Lafayette Hand-Held Dynamometer by Lafayette Instrument Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Back/leg/chest dynamometer, electronic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lafayette Instrument Company

Sources (1)

  • FDA UDI 7d1cf414-8b22-4cc4-a390-12b9b54f6948 36 fields · synced May 30, 2026