510(k) K150413
K150413 is an FDA 510(k) premarket notification submitted by Cymedica Orthopedics, Inc. for the device "QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator". The FDA issued a decision of Substantially Equivalent on Apr 2, 2015. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Cymedica Orthopedics, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 2, 2015
- Date Received
- Feb 18, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type
- 510(k)