510(k) K220578
K220578 is an FDA 510(k) premarket notification submitted by Bozhou Rongjian Medical Appliance Co., Ltd. for the device "Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)". The FDA issued a decision of Substantially Equivalent on May 25, 2022. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Bozhou Rongjian Medical Appliance Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2022
- Date Received
- February 28, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type