510(k) K200636
K200636 is an FDA 510(k) premarket notification submitted by Lhasa Oms, Inc. for the device "AXUS ES-5 Electro-Acupuncture Device". The FDA issued a decision of Substantially Equivalent on February 3, 2021. The device falls under product code BWK (Stimulator, Electro-Acupuncture), a Class U device. Lhasa Oms, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2021
- Date Received
- March 10, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electro-Acupuncture
- Device Class
- Class U
- Regulation Number
- Review Panel
- NE
- Submission Type