510(k) K770658
K770658 is an FDA 510(k) premarket notification submitted by Robert R. Moore for the device "EXERCISER, LEG, LOWER EXTREMITY". The FDA issued a decision of Substantially Equivalent on June 17, 1977. The device falls under product code ION (Exerciser, Non-Measuring), a Class I device regulated under 21 CFR 890.5370. Robert R. Moore has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 1977
- Date Received
- April 7, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exerciser, Non-Measuring
- Device Class
- Class I
- Regulation Number
- 890.5370
- Review Panel
- PM
- Submission Type