Question 1

What types of medical devices does Lafayette Instrument Company manufacture?

Accepted Answer

Lafayette Instrument Company specializes in manual and electronic measurement tools for clinical and research use. Their devices include hand dynamometers (both mechanical and electronic) for grip strength testing, goniometers (manual and electronic) for joint angle measurement, callipers (metallic, plastic, and skinfold) for body dimension and skin thickness assessment, and pneumographs for respiratory evaluation. These products are designed primarily for physical therapy, rehabilitation, and medical research settings.

Question 2

Where is Lafayette Instrument Company based?

Accepted Answer

Lafayette Instrument Company is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance context, particularly for devices marketed globally.

Question 3

Which regulatory registries list Lafayette Instrument Company’s devices?

Accepted Answer

Lafayette Instrument Company’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) system in the United States. These listings help ensure traceability and compliance with regulatory requirements in those regions.

Question 4

How are Lafayette Instrument Company’s devices classified under medical device regulations?

Accepted Answer

All devices produced by Lafayette Instrument Company fall under Class I regulatory classification. This classification applies to low-risk devices, such as manual measurement tools and simple diagnostic instruments, where the risk to patients is minimal. Class I devices typically require fewer regulatory controls but still must meet basic safety and performance standards.

Device	Model / Reference	Registries	Class	Status
Lafayette Skinfold Caliper	01128	FDA UDI	Class I	Active
Large Bone Caliper	01293	FDA UDI	Class I	Active
Small Bone Caliper	01294	FDA UDI	Class I	Active
Lafayette Hydraulic Pinch Gauge	5030P1	FDA UDI	Class I	Active
Pneumograph - Non-Metallic 14ft. Tubing	76513NM14	FDA UDI	Class I	Active
Pediatric Pneumograph - Non-Metallic w/10' Tubing	76513NM10K	FDA UDI	Class I	Active
Hand Evaluation Kit	J00109	FDA UDI	Class I	Active
Lafayette Hand-Held Dynamometer	01165	FDA UDI	Class I	Active
Lafayette Professional Grip Dynamometer	5030L1	FDA UDI	Class I	Active
Pneumograph - Non-Metallic 98in. Tubing	76513NM98C	FDA UDI	Class I	Active
Pneumograph - Non-Metallic 89in. Tubing	76513NM89	FDA UDI	Class I	Active
30cm Short Arm Anthropometer	01291A	FDA UDI	Class I	Active
DualGrip Digital Grip Dynamometer	5030DG	FDA UDI	Class I	Active
Lafayette Hydraulic Grip Dynamometer	J00105	FDA UDI	Class I	Active
Lafayette Range of Motion Inclinometer	ACU100	FDA UDI	Class I	Active
Pneumograph - Non-Metallic 18' w/Connector	76513NM18G	FDA UDI	Class I	Active
Pneumograph - Non-Metallic 12' w/Connector	76513NM12G	FDA UDI	Class I	Active
Pediatric Pneumograph - Non-Metallic w/89" Tubing	76513NM89K	FDA UDI	Class I	Active
Professional Hand Evaluation Kit	5030K1	FDA UDI	Class I	Active
Pneumograph - Non-Metallic 10ft. Tubing	76513NM10	FDA UDI	Class I	Active
Chest Depth Caliper	01140	FDA UDI	Class I	Active
Lafayette Extendable Goniometer	01135	FDA UDI	Class I	Active
70cm Long Arm Anthropometer	01290A	FDA UDI	Class I	Active
ROMI Dual Inclinometer System	ACU100-DUAL	FDA UDI	Class I	Active
Pneumograph Nonmetalic 135cm Strap	76513NM10B	FDA UDI	Class I	Active
Abdominal Caliper	01296	FDA UDI	Class I	Active
Pneumo Nonmetalic 10' Latex Free	76513NM10A	EUDAMEDFDA UDI	Class I	Active
Ped Nonmetal Pneumo 10' Latex Free	76513NM10P	EUDAMEDFDA UDI	Class I	Active
Ped Nonmetal Pneumo 89" Latex Free	76513NM89P	EUDAMEDFDA UDI	Class I	Active
Pneumo Nonmetalic 89" Latex Free	76513NM89A	EUDAMEDFDA UDI	Class I	Active
Lafayette Hand-Held Dynamometer	01165A	EUDAMEDFDA UDI	Class I	Active
Nonmetal Pneumo 12' Luer Latex Free	76513NM12M	EUDAMEDFDA UDI	Class I	Active

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