Submission Details
| 510(k) Number | K120783 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 15, 2012 |
| Decision Date | June 20, 2012 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
ABLE-X
Jun 2012
Decision
97d
Days
Class 1
Risk
About This 510(k) Submission
K120783 is an FDA 510(k) clearance for the ABLE-X, a Exerciser, Non-measuring (Class I — General Controls, product code ION), submitted by Im-Able, Ltd. (Palos Verdes Estates, US). The FDA issued a Cleared decision on June 20, 2012, 97 days after receiving the submission on March 15, 2012. 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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