Panels › Physical Medicine › Product code BXB · Class 1
Exerciser, Powered
Regulation 890.5380
0510(k)s in 12 months (160 all time)
0recalls in 12 months (6 all time)
1recalls that name a 510(k)
Top companies in BXB
| Company | 510(k)s | Recalls |
|---|---|---|
| Allied Associates, Inc. | 9 | 0 |
| Toronto Medical Corp. | 9 | 0 |
| Buckman Co., Inc. | 8 | 0 |
| Invacare Corp. | 8 | 0 |
| Sutter Corp. | 5 | 0 |
| Dyna Flex, Intl. | 4 | 0 |
| Sutter Biomedical, Inc. | 4 | 0 |
| Baltimore Therapeutic Equipment Co. | 3 | 0 |
| Biodex Medical Systems, Inc. | 3 | 0 |
| Danninger Medical Technology, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2024 | Btt Health Gmbh Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment Open, Classified |
BXB | None listed |
| Jul 29, 2019 | MOTEK MEDICAL B.V. Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairme Open, Classified |
BXB | None listed |
| Jul 31, 2013 | Accelerated Care Plus Corporation Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment int Terminated |
BXB | None listed |
| Dec 20, 2012 | BioMotion Medical Systems, LLC SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen that displays treatment time, positioning Terminated |
BXB | None listed |
| Aug 16, 2011 | Alter-G, Incorporated AlterG Anti-Gravity Treadmill;
Alter G, 48349 Milmont Drive, Fremont, Ca 94538
Product Usage: Rehabilitation of lower body injury & Neurological conditions. Terminated |
BXB | K072887 |
| Jan 7, 2010 | Hocoma AG Hocoma Lokomat-System with Pediatric Module
Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a, V5.0x.
Powered exercise equipment used to apply automated locomoter training for h Terminated |
BXB | None listed |
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