510(k) K854354
K854354 is an FDA 510(k) premarket notification submitted by Medical Technology and Innovations, Inc. for the device "THE BLEDSOE PASSIVE MOTION EXERCISER". The FDA issued a decision of Substantially Equivalent on February 6, 1986. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Medical Technology and Innovations, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 1986
- Date Received
- October 29, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exerciser, Powered
- Device Class
- Class I
- Regulation Number
- 890.5380
- Review Panel
- PM
- Submission Type