The following data is part of a premarket notification filed by Lhasa Oms, Inc. with the FDA for Axus Es-5 Electro-acupuncture Device.
| Device ID | K200636 |
| 510k Number | K200636 |
| Device Name: | AXUS ES-5 Electro-Acupuncture Device |
| Classification | Stimulator, Electro-acupuncture |
| Applicant | Lhasa OMS, INC. 230 Libbey Parkway Weymouth, MA 02189 |
| Contact | Colleen Pike |
| Correspondent | Saori Sawaki Ken Block Consulting, LLC 800 E. Campbell Road, Suite 202 Richardson, TX 75081 |
| Product Code | BWK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-10 |
| Decision Date | 2021-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14897076720092 | K200636 | 000 |