FDA product code LBE: Stroller, Adaptive
LBE is the FDA product code for stroller, adaptive. It is a Class I device, regulated under 21 CFR 890.3850 and reviewed by the Physical Medicine panel. FDA has cleared 8 510(k) submissions under LBE, 1 in the last five years, from 6 different applicants. The average 510(k) review took 80 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Stroller, Adaptive |
| Device class | Class I |
| Regulation | 21 CFR 890.3850 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LBE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 281 |
Compare with all 510(k) review times · Search every LBE clearance
Top LBE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Convaid Products, Inc. | 3 | 1984-02-09 |
| Ki Mobility, LLC | 1 | 2023-08-31 |
| Columbia Medical Mfg, LLC | 1 | 2013-10-16 |
| Asc Corp. | 1 | 1986-10-23 |
| Mednet, Inc. | 1 | 1986-08-13 |
1 more applicants have LBE clearances. See the full list in Caduvo.
Most recent LBE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223533 | Ki Mobility, LLC | Little Wave Arc; Little Wave Flip | 2023-08-31 | 281 |
| K130644 | Columbia Medical Mfg, LLC | PEDIATRIC FOLDING WHEELCHAIR | 2013-10-16 | 219 |
| K863450 | Asc Corp. | SULKY SPECIAL | 1986-10-23 | 50 |
| K862888 | Mednet, Inc. | PERAMBULATOR (STROLLER) | 1986-08-13 | 22 |
| K840250 | Convaid Products, Inc. | CARRIER | 1984-02-09 | 29 |
Recalls for LBE devices
openFDA lists no recalls for product code LBE.
Frequently asked questions
What is FDA product code LBE?
LBE is the FDA product code for stroller, adaptive. It is a Class I device, regulated under 21 CFR 890.3850 and reviewed by the Physical Medicine panel.
What device class is LBE?
Class I, regulation 21 CFR 890.3850. Typical premarket route: 510(k).
How long does a 510(k) take for product code LBE?
Across 8 cleared submissions the average was 80 days from receipt to decision (median 26).
Which companies have the most LBE clearances?
Convaid Products, Inc. (3); Ki Mobility, LLC (1); Columbia Medical Mfg, LLC (1); Asc Corp. (1); Mednet, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LBE
- Run a recall and safety report across every LBE manufacturer
- Watch product code LBE 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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