E-STIM II

Stimulator, Nerve, Transcutaneous, For Pain Relief

LHASA OMS, INC.

The following data is part of a premarket notification filed by Lhasa Oms, Inc. with the FDA for E-stim Ii.

Pre-market Notification Details

• Device ID: K050435
• 510k Number: K050435
• Device Name: E-STIM II
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: LHASA OMS, INC. 230 LIBBEY PKWY. Weymouth, MA 02189
• Contact: Mark W Sheehan
• Correspondent: Mark W Sheehan; LHASA OMS, INC. 230 LIBBEY PKWY. Weymouth, MA 02189
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-02-22
• Decision Date: 2005-09-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
14897076720030	K050435	000