The following data is part of a premarket notification filed by Unique Functional Products with the FDA for Gravity King (deemed Se 87/09/18).
| Device ID | K851065 |
| 510k Number | K851065 |
| Device Name: | GRAVITY KING (DEEMED SE 87/09/18) |
| Classification | Exerciser, Non-measuring |
| Applicant | UNIQUE FUNCTIONAL PRODUCTS 135 SUNSHINE LN. San Marcos, CA 92069 |
| Contact | Timothy B Tucker |
| Correspondent | Timothy B Tucker UNIQUE FUNCTIONAL PRODUCTS 135 SUNSHINE LN. San Marcos, CA 92069 |
| Product Code | ION |
| CFR Regulation Number | 890.5370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-15 |
| Decision Date | 1985-06-13 |