Submission Details
| 510(k) Number | K003272 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 18, 2000 |
| Decision Date | April 04, 2001 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
FLO-BOOT
Apr 2001
Decision
168d
Days
Class 1
Risk
About This 510(k) Submission
K003272 is an FDA 510(k) clearance for the FLO-BOOT, a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Discovery Group, LLC (Richmond, US). The FDA issued a Cleared decision on April 4, 2001, 168 days after receiving the submission on October 18, 2000. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.
Device Classification
| Product Code | BXB — Exerciser, Powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5380 |
Manufacturer
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