510(k) K800716
K800716 is an FDA 510(k) premarket notification submitted by Ipos Luneburg for the device "ORTHOTIC LEG GAIT CORRECTOR DEVICE". The FDA issued a decision of Substantially Equivalent on May 2, 1980. The device falls under product code ITO (Twister, Brace Setting), a Class I device regulated under 21 CFR 890.3410. Ipos Luneburg has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1980
- Date Received
- March 31, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Twister, Brace Setting
- Device Class
- Class I
- Regulation Number
- 890.3410
- Review Panel
- PM
- Submission Type