LBE · Stroller, Adaptive
Physical Medicine · 21 CFR 890.3850 · Class 1
Overview
| Product Code | LBE |
|---|---|
| Device Name | Stroller, Adaptive |
| Regulation | 21 CFR 890.3850 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Classification Rationale
Class I (general controls).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K223533 | Little Wave Arc; Little Wave Flip | Ki Mobility, LLC | Aug 31, 2023 | SESE |
| K130644 | PEDIATRIC FOLDING WHEELCHAIR | Columbia Medical Mfg, LLC | Oct 16, 2013 | SESE |
| K863450 | SULKY SPECIAL | Asc Corp. | Oct 23, 1986 | SESE |
| K862888 | PERAMBULATOR (STROLLER) | Mednet, Inc. | Aug 13, 1986 | SESE |
| K840250 | CARRIER | Convaid Products, Inc. | Feb 9, 1984 | SESE |
| K820591 | MECHANICAL CHAIR | Kaye Products, Inc. | Mar 15, 1982 | SESE |
| K810676 | CONVAID CRUISER CP4M | Convaid Products, Inc. | Mar 26, 1981 | SESE |
| K781947 | STROLLER, THERAPY | Convaid Products, Inc. | Dec 4, 1978 | SESE |
Top Applicants
- Convaid Products, Inc. — 3 clearances
- Asc Corp. — 1 clearance
- Columbia Medical Mfg, LLC — 1 clearance
- Kaye Products, Inc. — 1 clearance
- Ki Mobility, LLC — 1 clearance
