510(k) K863450
- Device
- SULKY SPECIAL
- Applicant
- ASC CORP.
- 510(k) number
- K863450
- Product code
- LBE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-10-23
- Date received
- 1986-09-03
- Regulation
- 890.3850
- Classification name
- Stroller, Adaptive
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- OLAV H BRANNSTROM
- Address
- 6518 Denton Dr. Troy MI US 48098 48098
FDA Registration Numbers#
- 3005905321
- 3043237012
- 3001657382
- 3043748437
- 2022883
- 3007675960
- 3004727093
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K130644 | PEDIATRIC FOLDING WHEELCHAIR | Columbia Medical Mfg, LLC | 2013-10-16 |
| 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#
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FDA Review#
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