X-FORCE

Stimulator, Electrical, Transcutaneous, For Arthritis

SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC

The following data is part of a premarket notification filed by Seven Seas Distribtion And Manufacturing Llc with the FDA for X-force.

Pre-market Notification Details

• Device ID: K111557
• 510k Number: K111557
• Device Name: X-FORCE
• Classification: Stimulator, Electrical, Transcutaneous, For Arthritis
• Applicant: SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC 2620 S MARYLAND PKWY STE 14 UNIT 835 Las Vegas, NV 89109
• Contact: Mark Ioele
• Correspondent: Mark Ioele; SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC 2620 S MARYLAND PKWY STE 14 UNIT 835 Las Vegas, NV 89109
• Product Code: NYN
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-03
• Decision Date: 2011-11-10
• Summary: summary