Identity
- Trade Name
- Lafayette Hand-Held Dynamometer EUDAMEDFDA UDI
- Generic Name
- Back/leg/chest dynamometer, electronic FDA UDI
- Device Name
- Lafayette Hand-Held Dynamometer EUDAMEDThe 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
- 01165A EUDAMEDFDA 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
- 01165A FDA UDI
- Primary DI / UDI-DI
- 00855170007379 EUDAMEDFDA UDI
- Basic UDI-DI
- 0855170007STRENGTHTESTV9 EUDAMED
- FDA Product Code
- KQX FDA UDI
- EMDN Code
- V0399 MEASUREMENT DEVICES - OTHER EUDAMED
- GMDN Term
- Back/leg/chest dynamometer, electronic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Lafayette Hand-Held Dynamometer by Lafayette Instrument Company — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0855170007STRENGTHTESTV9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Lafayette Instrument Company
- EUDAMED SRN
- US-MF-000041816
- Authorised Representative
- AJW Technology Consulting GmbH DE-AR-000004999
Sources (2)
- EUDAMED 93ee31f4-4686-4755-96a9-86bc36f6c00d 61 fields · synced Jun 19, 2026
- FDA UDI 99fec59c-adf9-492a-ba59-4cff4046afb6 36 fields · synced May 29, 2026