UNI-TENS

Stimulator, Nerve, Transcutaneous, For Pain Relief

SOLCOOR, INC.

The following data is part of a premarket notification filed by Solcoor, Inc. with the FDA for Uni-tens.

Pre-market Notification Details

• Device ID: K861895
• 510k Number: K861895
• Device Name: UNI-TENS
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: SOLCOOR, INC. 1655 N. FT. MYER DR. STE. 700 Arlington, VA 22209
• Contact: Barbara Marsden
• Correspondent: Barbara Marsden; SOLCOOR, INC. 1655 N. FT. MYER DR. STE. 700 Arlington, VA 22209
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-05-16
• Decision Date: 1986-09-09