510(k) K202671
K202671 is an FDA 510(k) premarket notification submitted by Guangzhou Xinbo Electronic Co., Ltd. for the device "DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)". The FDA issued a decision of Substantially Equivalent on November 12, 2021. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Guangzhou Xinbo Electronic Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2021
- Date Received
- September 14, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES