510(k) K233092
K233092 is an FDA 510(k) premarket notification submitted by Chongqing Rob Linka Science and Technology Co., Ltd. for the device "Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)". The FDA issued a decision of Substantially Equivalent on February 12, 2024. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Chongqing Rob Linka Science and Technology Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2024
- Date Received
- September 26, 2023
- 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