510(k) K790528
K790528 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "THERAPY GYROSCOPE". The FDA issued a decision of Substantially Equivalent on April 3, 1979. The device falls under product code KNL (Board, Scooter, Prone), a Class I device regulated under 21 CFR 890.5370. Maddak, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 1979
- Date Received
- March 15, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Board, Scooter, Prone
- Device Class
- Class I
- Regulation Number
- 890.5370
- Review Panel
- PM
- Submission Type