LBE — Stroller, Adaptive Class I
FDA product code LBE covers "Stroller, Adaptive", a Class I medical device regulated under 21 CFR 890.3850. Submissions are reviewed by the Physical Medicine panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LBE
- Device Class
- Class I
- Regulation Number
- 890.3850
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223533 | ki mobility | Little Wave Arc; Little Wave Flip | August 31, 2023 |
| K130644 | columbia medical mfg | PEDIATRIC FOLDING WHEELCHAIR | October 16, 2013 |
| K863450 | asc | SULKY SPECIAL | October 23, 1986 |
| K862888 | mednet | PERAMBULATOR (STROLLER) | August 13, 1986 |
| K840250 | convaid products | CARRIER | February 9, 1984 |
| K820591 | kaye products | MECHANICAL CHAIR | March 15, 1982 |
| K810676 | convaid products | CONVAID CRUISER CP4M | March 26, 1981 |
| K781947 | convaid products | STROLLER, THERAPY | December 4, 1978 |