TENS STIMULATOR, MODELS 2800 AND 3000

Stimulator, Nerve, Transcutaneous, For Pain Relief

KOALATY PRODUCTS, INC.

The following data is part of a premarket notification filed by Koalaty Products, Inc. with the FDA for Tens Stimulator, Models 2800 And 3000.

Pre-market Notification Details

• Device ID: K102014
• 510k Number: K102014
• Device Name: TENS STIMULATOR, MODELS 2800 AND 3000
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: KOALATY PRODUCTS, INC. # 3 BLDG, XILIYANGGUANG IND ES XILIAOBAIMANG Shenzhen, Guangdong, CN 518108
• Contact: Kang Jiang Ping
• Correspondent: Jeffrey D Rongero; UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2010-07-16
• Decision Date: 2010-08-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
80813520010772	K102014	000