Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart D — Physical Medicine Prosthetic Devices](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices) → [21 CFR 890.3850](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3850) → LBE — Stroller, Adaptive

# LBE · Stroller, Adaptive

_Physical Medicine · 21 CFR 890.3850 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/LBE

## Overview

- **Product Code:** LBE
- **Device Name:** Stroller, Adaptive
- **Regulation:** [21 CFR 890.3850](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3850)
- **Device Class:** 1
- **Review Panel:** [Physical Medicine](/submissions/PM)
- **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](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/LBE/K223533.md) | Little Wave Arc; Little Wave Flip | Ki Mobility, LLC | Aug 31, 2023 | SESE |
| [K130644](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/LBE/K130644.md) | PEDIATRIC FOLDING WHEELCHAIR | Columbia Medical Mfg, LLC | Oct 16, 2013 | SESE |
| [K863450](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/LBE/K863450.md) | SULKY SPECIAL | Asc Corp. | Oct 23, 1986 | SESE |
| [K862888](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/LBE/K862888.md) | PERAMBULATOR (STROLLER) | Mednet, Inc. | Aug 13, 1986 | SESE |
| [K840250](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/LBE/K840250.md) | CARRIER | Convaid Products, Inc. | Feb 9, 1984 | SESE |
| [K820591](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/LBE/K820591.md) | MECHANICAL CHAIR | Kaye Products, Inc. | Mar 15, 1982 | SESE |
| [K810676](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/LBE/K810676.md) | CONVAID CRUISER CP4M | Convaid Products, Inc. | Mar 26, 1981 | SESE |
| [K781947](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/LBE/K781947.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/LBE](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/LBE)

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