510(k) K884787
K884787 is an FDA 510(k) premarket notification submitted by Medical Alignment Systems for the device "ACCULITE-PPL 5". The FDA issued a decision of Substantially Equivalent on January 24, 1989. The device falls under product code INE (Sling, Overhead Suspension, Wheelchair), a Class I device regulated under 21 CFR 890.3910. Medical Alignment Systems has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 1989
- Date Received
- November 15, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sling, Overhead Suspension, Wheelchair
- Device Class
- Class I
- Regulation Number
- 890.3910
- Review Panel
- PM
- Submission Type