Identity
- Trade Name
- Professional Hand Evaluation Kit FDA UDI
- Generic Name
- Hand dynamometer/pinchmeter, mechanical FDA UDI
- Device Name
- The Lafayette Grip or Pinch Dynamometers are hydraulic strength measuring instruments. They are designed for routine assessment of the grip and/or pinch strength of a patient or can also be used in the evaluation of hand trauma or disease. As the patient either grips or pinches the device, a column of hydraulic fluid activates a pressure gauge mounted on the top of the device. The gauge indicates the pinch or grip force in pounds (lbs) or kilogram force (kgf). A peak needle shows the maximum force applied during a single test. The peak needle is manually reset at the end of the test and peak values are recorded manually. The grip dynamometers also feature an adjustable handle that can accommodate five different grip positions. The Stainless Steel Short Finger Goniometer is used for easy range-of-motion measurements of metacarpal, phalangeal, and interphalangeal joints. There are linear inch and centimeter markings on both sides of the protractors, in opposite directions. The protractors measure 0-150° in 5° increments. Stainless steel. Latex free. Clearly marked numbers make measuring easy. Measures 5.75 inches long. FDA UDI
- Model / Reference
- 5030K1 FDA UDI
- Description
- The Lafayette Grip or Pinch Dynamometers are hydraulic strength measuring instruments. They are designed for routine assessment of the grip and/or pinch strength of a patient or can also be used in the evaluation of hand trauma or disease. As the patient either grips or pinches the device, a column of hydraulic fluid activates a pressure gauge mounted on the top of the device. The gauge indicates the pinch or grip force in pounds (lbs) or kilogram force (kgf). A peak needle shows the maximum force applied during a single test. The peak needle is manually reset at the end of the test and peak values are recorded manually. The grip dynamometers also feature an adjustable handle that can accommodate five different grip positions. The Stainless Steel Short Finger Goniometer is used for easy range-of-motion measurements of metacarpal, phalangeal, and interphalangeal joints. There are linear inch and centimeter markings on both sides of the protractors, in opposite directions. The protractors measure 0-150° in 5° increments. Stainless steel. Latex free. Clearly marked numbers make measuring easy. Measures 5.75 inches long. FDA UDI
Identifiers
- Catalog Number
- 5030K1 FDA UDI
- Primary DI / UDI-DI
- 00855170007119 FDA UDI
- FDA Product Code
- HRW FDA UDIKQW FDA UDI
- GMDN Term
- Hand dynamometer/pinchmeter, mechanical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1250 FDA UDI888.1520 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
Yes
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: Manual goniometerHand dynamometer/pinchmeter, mechanical
Professional Hand Evaluation Kit by Lafayette Instrument Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Lafayette Instrument Company
Sources (1)
- FDA UDI 41facf4b-2b74-4b28-84f4-08b483d3868d 36 fields · synced Jun 8, 2026