FDA product code LBB: Dynamometer, Ac-Powered
LBB is the FDA product code for dynamometer, ac-powered. It is a Class II device, regulated under 21 CFR 888.1240 and reviewed by the Neurology panel. FDA has cleared 36 510(k) submissions under LBB, from 21 different applicants. The average 510(k) review took 110 days (median 90). FDA has posted 2 recalls for LBB devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dynamometer, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 888.1240 |
| Review panel | NE — Neurology |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
510(k) clearances per year for LBB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 192 |
Compare with all 510(k) review times · Search every LBB clearance
Top LBB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nk Biotechnical Engineering Co. | 10 | 1993-05-12 |
| Chattanooga Group, Inc. | 4 | 1990-10-01 |
| John Chatillon & Sons, Inc. | 3 | 1997-01-27 |
| Greenleaf Medical Systems, Inc. | 2 | 1994-04-15 |
| Hoggan Scientific, LLC | 1 | 2017-03-09 |
16 more applicants have LBB clearances. See the full list in Caduvo.
Most recent LBB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162412 | Hoggan Scientific, LLC | Hoggan Scientific® microFET2 | 2017-03-09 | 192 |
| K073154 | Global Services Group, LLC | FACTS HAND AND PINCH GRIP COMBO | 2008-02-14 | 98 |
| K052309 | Saehan Corp. | DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 | 2005-09-27 | 34 |
| K042889 | Ametek | DYNAMOMETER - MODEL FCE AND MODEL MSC | 2004-11-16 | 28 |
| K012492 | Kada Research, Inc. | KADANCE 2000 | 2001-11-02 | 91 |
Recalls for LBB devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2021-11-30.
| Year | Recalls |
|---|---|
| 2021 | 2 |
Frequently asked questions
What is FDA product code LBB?
LBB is the FDA product code for dynamometer, ac-powered. It is a Class II device, regulated under 21 CFR 888.1240 and reviewed by the Neurology panel.
What device class is LBB?
Class II, regulation 21 CFR 888.1240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LBB?
Across 36 cleared submissions the average was 110 days from receipt to decision (median 90).
Which companies have the most LBB clearances?
Nk Biotechnical Engineering Co. (10); Chattanooga Group, Inc. (4); John Chatillon & Sons, Inc. (3); Greenleaf Medical Systems, Inc. (2); Hoggan Scientific, LLC (1).
Have LBB devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2021-11-30.
Next steps
- Run an FDA pathway report with predicate devices for product code LBB
- Run a recall and safety report across every LBB manufacturer
- Watch product code LBB 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.
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