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510(k) Data Aggregation
K Number
K990813Device Name
REHCOR
Manufacturer
ELECTROMED CORP.
Date Cleared
1999-04-12
(32 days)
Product Code
ISD, MEA
Regulation Number
890.5360Why did this record match?
Applicant Name (Manufacturer) :
ELECTROMED CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Useful for physiotherapy in redevelopment of muscles or for restoration of motion to joints or for use as an adjunct treatment for obesity. The bicycle would be Class I exempt when sold without measuring capability but is available with ECG and/or blood pressure measuring options thus making it Class II, not exempt. The unit's workload can be controlled by an RS-232 input for connection to ECG stress test systems (supplied by other manufacturers)
Device Description
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