510(k) K201290
K201290 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "Medline DeNovo 4Pro Electrical Stimulation Device". The FDA issued a decision of Substantially Equivalent on Sep 21, 2020. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Medline Industries, Inc. has 268 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 21, 2020
- Date Received
- May 14, 2020
- Clearance Type
- Traditional
- 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)