510(k) K202110
K202110 is an FDA 510(k) premarket notification submitted by Guangzhou Longest Science & Technology Co., Ltd. for the device "MStim Drop Model: LGT-233". The FDA issued a decision of Substantially Equivalent on November 5, 2021. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Guangzhou Longest Science & Technology Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 2021
- Date Received
- July 30, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Neuromuscular, External Functional
- Device Class
- Class II
- Regulation Number
- 882.5810
- Review Panel
- NE
- Submission Type