510(k) K912056
K912056 is an FDA 510(k) premarket notification submitted by Tri-Tech, Inc. for the device "GRAVITRON UPPER BODY SYSTEM EXERCISER". The FDA issued a decision of Substantially Equivalent on October 24, 1991. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. Tri-Tech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 1991
- Date Received
- May 9, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exerciser, Measuring
- Device Class
- Class II
- Regulation Number
- 890.5360
- Review Panel
- PM
- Submission Type