Submission Details
| 510(k) Number | K851065 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 15, 1985 |
| Decision Date | June 13, 1985 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
Cleared
Traditional
GRAVITY KING (DEEMED SE 87/09/18)
Jun 1985
Decision
90d
Days
Class 1
Risk
About This 510(k) Submission
K851065 is an FDA 510(k) clearance for the GRAVITY KING (DEEMED SE 87/09/18), a Exerciser, Non-measuring (Class I — General Controls, product code ION), submitted by Unique Functional Products (San Marcos, US). The FDA issued a Cleared decision on June 13, 1985, 90 days after receiving the submission on March 15, 1985. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5370.
Device Classification
| Product Code | ION — Exerciser, Non-measuring |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5370 |
Manufacturer
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