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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K800380
Device Name FES ORTHOSIS MODEL NO. 2000
Applicant
EMPI
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
EMPI
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number882.5810
Classification Product Code
GZI  
Date Received02/22/1980
Decision Date 03/17/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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