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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K884210
Device Name TX-7 (TENS) (IC-1107)
Applicant
OMS MEDICAL SUPPLIES, INC.
1950 WASHINGTON ST.
BRAINTREE,  MA  02184
Applicant Contact A RIIHIMAKI
Correspondent
OMS MEDICAL SUPPLIES, INC.
1950 WASHINGTON ST.
BRAINTREE,  MA  02184
Correspondent Contact A RIIHIMAKI
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/06/1988
Decision Date 12/12/1988
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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