TENS

Stimulator, Nerve, Transcutaneous, Over-the-counter

SUNMAS (H.K.) TRADING LIMITED

The following data is part of a premarket notification filed by Sunmas (h.k.) Trading Limited with the FDA for Tens.

Pre-market Notification Details

• Device ID: K133979
• 510k Number: K133979
• Device Name: TENS
• Classification: Stimulator, Nerve, Transcutaneous, Over-the-counter
• Applicant: SUNMAS (H.K.) TRADING LIMITED PO BOX 237-023 Shanghai, CN 200237
• Contact: Diana Hong
• Correspondent: Diana Hong; SUNMAS (H.K.) TRADING LIMITED PO BOX 237-023 Shanghai, CN 200237
• Product Code: NUH
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-12-26
• Decision Date: 2014-08-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20370914013019	K133979	000
20370914012005	K133979	000