510(k) K900759
K900759 is an FDA 510(k) premarket notification submitted by Nu-Gyn-Tek, Inc. for the device "POLY-OP (TM)". The FDA issued a decision of Substantially Equivalent on May 24, 1990. The device falls under product code OCF (Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief), a Class II device regulated under 21 CFR 882.5890. Nu-Gyn-Tek, Inc. has at least 1 other 510(k) clearance on record.
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).