LBE
8 FDA 510(k) clearances · Product code
29 daysmedian time to decision
281 days90th percentile
8clearances measured
FDA profile
- Official device name
- Stroller, Adaptive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3850
- Medical specialty
- Physical Medicine
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1997: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Little Wave Arc; Little Wave Flip (K223533) | Ki Mobility, LLC | 2023-08-31 |
| PEDIATRIC FOLDING WHEELCHAIR (K130644) | Columbia Medical Mfg, LLC | 2013-10-16 |
| SULKY SPECIAL (K863450) | Asc Corp. | 1986-10-23 |
| PERAMBULATOR (STROLLER) (K862888) | Mednet, Inc. | 1986-08-13 |
| CARRIER (K840250) | Convaid Products, Inc. | 1984-02-09 |
| MECHANICAL CHAIR (K820591) | Kaye Products, Inc. | 1982-03-15 |
| CONVAID CRUISER CP4M (K810676) | Convaid Products, Inc. | 1981-03-26 |
| STROLLER, THERAPY (K781947) | Convaid Products, Inc. | 1978-12-04 |
Track LBE automatically
Every clearance here is in the API, with alerts when new ones post.