510(k) K171387
K171387 is an FDA 510(k) premarket notification submitted by Elite Medical Supply Of New York, LLC for the device "EMS100 Tri-Wave Combination Stimulator". The FDA issued a decision of Substantially Equivalent on May 31, 2017. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2017
- Date Received
- May 11, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type
- 510(k)