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510(k) Data Aggregation
K Number
K991313Device Name
ACCUTRED SHOE
Manufacturer
ORTHOPEDIC TECHNOLOGY RESEARCH, INC.
Date Cleared
1999-06-23
(68 days)
Product Code
IRN
Regulation Number
890.5575Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPEDIC TECHNOLOGY RESEARCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AccuTread™ Shoe System is intended for use as a limb load monitoring device to assist in the rehabilitation of patients with insults to their lower extremities. The AccuTread™ Shoe System is intended to be used in any situation in which a therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.
Device Description
Not Found
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K Number
K960307Device Name
INDEX SHOE
Manufacturer
ORTHOPEDIC TECHNOLOGY RESEARCH, INC.
Date Cleared
1996-06-27
(157 days)
Product Code
IRN
Regulation Number
890.5575Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPEDIC TECHNOLOGY RESEARCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AccuTread™ Shoe is intended for use as a limb load monitoring device to monitor limited weight bearing during rehabilitation of patients with insults to their lower extremities.
Device Description
The AccuTread™ Shoe is a shoe-like enclosure, worn by patients having insults to their lower extremities. The device is intended for use to achieve benefits such as:
- protection of the affected extremity during the healing process, .
- . ease of mind during initial ambulation, and
- documentation of compliance or non-compliance to a prescribed weight ● bearing program.
These benefits derive from the patient's ability to know that he/she is not exceeding the correct amount of weight applied to the affected extremity as prescribed by their physician. The complete device consists of the following components:
- Shoe Body .
- Sensor Unit
- Transmitter .
- . Receiver
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