Perambulator (Stroller)
FDA 510(k) K862888 · Mednet, Inc.
510(k) numberK862888
Submission
- Device name
- Perambulator (Stroller)
- Applicant
- Mednet, Inc.
Battle Creek, MI, US - Received
- July 22, 1986
- Decision date
- August 13, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LBE – Stroller, Adaptive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3850
- Specialty
- Physical Medicine
Other 510(k)s with product code LBE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223533 | Little Wave Arc; Little Wave FlipLBE · Traditional | Ki Mobility, LLC | 08/31/2023SE |
| K130644 | Pediatric Folding WheelchairLBE · Abbreviated | Columbia Medical Mfg, LLC | 10/16/2013SE |
| K863450 | Sulky SpecialLBE · Traditional | Asc Corp. | 10/23/1986SE |
| K840250 | CarrierLBE · Traditional | Convaid Products, Inc. | 02/09/1984SE |
| K820591 | Mechanical ChairLBE · Traditional | Kaye Products, Inc. | 03/15/1982SE |
| K810676 | Convaid Cruiser CP4MLBE · Traditional | Convaid Products, Inc. | 03/26/1981SE |
| K781947 | Stroller, TherapyLBE · Traditional | Convaid Products, Inc. | 12/04/1978SE |
More from Convaid Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955782 | Med-Net StopcocksFMG · Traditional | 02/21/1996SE |
| K862892 | Caster CarIOR · Traditional | 08/14/1986SE |
| K862887 | Upholstered Bucket SeatKNN · Traditional | 08/14/1986SE |
| K862885 | Car SeatINN · Traditional | 08/14/1986SE |
| K862883 | Orthopedic SeatsINN · Traditional | 08/14/1986SE |
| K862895 | TricyclesIKX · Traditional | 08/13/1986SE |
| K862894 | SchooltableINW · Traditional | 08/13/1986SE |
| K862893 | Ventral Standing Unit · Traditional | 08/13/1986SE |
| K862890 | Toilet/Shower ChairIOR · Traditional | 08/13/1986SE |
| K862889 | Kiro, Wheelchair for ChildrenIOR · Traditional | 08/13/1986SE |
Questions and answers
When was Perambulator (Stroller) cleared by the FDA?
Perambulator (Stroller) (K862888) received a 510(k) decision of Substantially Equivalent on August 13, 1986, 22 days after the submission was received.
What is the product code of K862888?
The FDA product code is LBE – Stroller, Adaptive, a Class I (low risk) device regulated under 21 CFR 890.3850.