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510(k) Data Aggregation
K Number
K955034Device Name
FORCEGUARD
Manufacturer
IMPACT MONITORS, INC.
Date Cleared
1996-04-10
(160 days)
Product Code
IRN
Regulation Number
890.5575Why did this record match?
Applicant Name (Manufacturer) :
IMPACT MONITORS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ForceGuard is used to sense the amount of weight applied to the plantar surface of the foot. The device alerts the wearer and/or therapist with a repeating tone when the weight exceeds the pre-selected value.
ForceGuard will be used on patients who have bone, connective tissue or soft tissue damage who also have been instructed by a physician to limit the weight being placed on a lower limb.
Device Description
ForceGuard Model 2090 consists of 3 components; footpad, electronics module, and leg band. The leg band is worn around the patient's ankle. The electronics module attaches to the leg band. The footpad, a flexible, fluid filled chamber, plugs into the electronics module and is worn under the plantar surface of the patient's foot inside suitable footwear.
The function of the leg band is to secure the electronics module to the patient's ankle. The function of the footpad is to sense the weight being placed through the patient's lower extremity. The electronics module functions as the user interface, processes information from the footpad and alarms when the weight on the footpad exceeds the selected weight.
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