510(k) K900759

POLY-OP (TM) by Nu-Gyn-Tek, Inc. — Product Code OCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1990
Date Received
February 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Electrical stimulation of nerves for relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). Relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).