510(k) K871981
K871981 is an FDA 510(k) premarket notification submitted by Avec Scientific Design Corp. for the device "BILATERAL CONTINUOUS PASSIVE MOTION DEVICE". The FDA issued a decision of Substantially Equivalent on June 17, 1987. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Avec Scientific Design Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 1987
- Date Received
- May 22, 1987
- 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