FDA product code BXB: Exerciser, Powered
BXB is the FDA product code for exerciser, powered. It is a Class I device, regulated under 21 CFR 890.5380 and reviewed by the Physical Medicine panel. FDA has cleared 160 510(k) submissions under BXB, from 98 different applicants. The average 510(k) review took 119 days (median 72). FDA has posted 6 recalls for BXB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Exerciser, Powered |
| Device class | Class I |
| Regulation | 21 CFR 890.5380 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BXB clearance
Top BXB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Allied Associates, Inc. | 9 | 1984-08-02 |
| Buckman Co., Inc. | 8 | 1993-03-22 |
| Invacare Corp. | 8 | 1989-03-15 |
| Toronto Medical Corp. | 7 | 1995-09-13 |
| Sutter Corp. | 5 | 1995-02-27 |
93 more applicants have BXB clearances. See the full list in Caduvo.
Most recent BXB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072887 | Alter-G, Inc. | G-TRAINER MEDICAL | 2008-01-25 | 107 |
| K003272 | Discovery Group, LLC | FLO-BOOT | 2001-04-04 | 168 |
| K952975 | Prevent Products, Inc. | ANKLE CALF EXERCISER PHLEBOPUMP | 1996-09-25 | 456 |
| K953456 | Fluid Motion Biotechnologies, Inc. | E-Z FLEX | 1996-01-26 | 191 |
| K955105 | Baltimore Therapeutic Equipment Co. | BTE CPM-10 | 1995-12-29 | 51 |
Recalls for BXB devices
6 product recalls in 6 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2024-08-01.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code BXB?
BXB is the FDA product code for exerciser, powered. It is a Class I device, regulated under 21 CFR 890.5380 and reviewed by the Physical Medicine panel.
What device class is BXB?
Class I, regulation 21 CFR 890.5380. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BXB?
Across 160 cleared submissions the average was 119 days from receipt to decision (median 72).
Which companies have the most BXB clearances?
Allied Associates, Inc. (9); Buckman Co., Inc. (8); Invacare Corp. (8); Toronto Medical Corp. (7); Sutter Corp. (5).
Have BXB devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2024-08-01.
Next steps
- Run an FDA pathway report with predicate devices for product code BXB
- Run a recall and safety report across every BXB manufacturer
- Watch product code BXB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times