510(k) K851065
K851065 is an FDA 510(k) premarket notification submitted by Unique Functional Products for the device "GRAVITY KING (DEEMED SE 87/09/18)". The FDA issued a decision of Substantially Equivalent on June 13, 1985. The device falls under product code ION (Exerciser, Non-Measuring), a Class I device regulated under 21 CFR 890.5370.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1985
- Date Received
- March 15, 1985
- 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