510(k) K091248
K091248 is an FDA 510(k) premarket notification submitted by Bio Protech, Inc. for the device "MAXEMS, MODELS 1000 AND 2000". The FDA issued a decision of Substantially Equivalent on November 30, 2009. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Bio Protech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2009
- Date Received
- April 28, 2009
- 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