510(k) K130644
- Device
- PEDIATRIC FOLDING WHEELCHAIR
- Applicant
- COLUMBIA MEDICAL MFG, LLC
- 510(k) number
- K130644
- Product code
- LBE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-10-16
- Date received
- 2013-03-11
- Regulation
- 890.3850
- Classification name
- Stroller, Adaptive
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARY WERSCHMIDT
- Address
- 11724 Willake St. Santa Fe Springs CA US 90670 90670
FDA Registration Numbers#
- 3004727093
- 2022883
- 3001657382
- 3043748437
- 3043237012
- 3005905321
- 3007675960
Source Documents#
Other 510(k) Records For Product Code LBE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223533 | Little Wave Arc; Little Wave Flip | Ki Mobility, LLC | 2023-08-31 |
| K863450 | SULKY SPECIAL | Asc Corp. | 1986-10-23 |
| K862888 | PERAMBULATOR (STROLLER) | Mednet, Inc. | 1986-08-13 |
| K840250 | CARRIER | Convaid Products, Inc. | 1984-02-09 |
| K820591 | MECHANICAL CHAIR | Kaye Products, Inc. | 1982-03-15 |
| K810676 | CONVAID CRUISER CP4M | Convaid Products, Inc. | 1981-03-26 |
| K781947 | STROLLER, THERAPY | Convaid Products, Inc. | 1978-12-04 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases