Stroller, Adaptive
An adaptive stroller is a specialized mobility device designed to provide supported seating and transport for pediatric or adult patients with physical disabilities who cannot use standard strollers or wheelchairs. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls such as proper labeling and manufacturing standards, with no premarket notification needed. The product code is LBE, regulated under 21 CFR 890.3850, in the Physical Medicine specialty. It is eligible for third-party review.
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Basic Information
- Product Code
- LBE
- Device Class
- FDA class 1
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K223533 | Little Wave Arc; Little Wave Flip | Aug 31, 2023 | Substantially Equivalent | Ki Mobility, LLC |
| K130644 | PEDIATRIC FOLDING WHEELCHAIR | Oct 16, 2013 | Substantially Equivalent | Columbia Medical Mfg, LLC |
| K863450 | SULKY SPECIAL | Oct 23, 1986 | Substantially Equivalent | Asc Corp. |
| K862888 | PERAMBULATOR (STROLLER) | Aug 13, 1986 | Substantially Equivalent | Mednet, Inc. |
| K840250 | CARRIER | Feb 09, 1984 | Substantially Equivalent | Convaid Products, Inc. |
| K820591 | MECHANICAL CHAIR | Mar 15, 1982 | Substantially Equivalent | Kaye Products, Inc. |
| K810676 | CONVAID CRUISER CP4M | Mar 26, 1981 | Substantially Equivalent | Convaid Products, Inc. |
| K781947 | STROLLER, THERAPY | Dec 04, 1978 | Substantially Equivalent | Convaid Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.