Submission Details
| 510(k) Number | K932240 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 07, 1993 |
| Decision Date | April 01, 1994 |
| Days to Decision | 329 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
Cleared
Traditional
K932240 - MODEL 5200-10,5200-12 HI-LOW ELEC. PARRALLEL BARS
(FDA 510(k) Clearance)
Apr 1994
Decision
329d
Days
Class 1
Risk
K932240 is an FDA 510(k) clearance for the MODEL 5200-10,5200-12 HI-LOW ELEC. PARRALLEL BARS. This device is classified as a Bars, Parallel, Powered (Class I — General Controls, product code IRR).
Submitted by Bailey Mfg. Co. (Lodi, US). The FDA issued a Cleared decision on April 1, 1994, 329 days after receiving the submission on May 7, 1993.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5380.
Device Classification
| Product Code | IRR — Bars, Parallel, Powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5380 |