Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002
FDA 510(k) K081264 · Children'S Health First, Inc.
510(k) numberK081264
Submission
- Device name
- Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002
- Applicant
- Children'S Health First, Inc.
Carlsbad, CA, US - Received
- May 5, 2008
- Decision date
- February 13, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMQ – Restraint, Protective
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6760
- Specialty
- General Hospital
Other 510(k)s with product code FMQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110377 | Protective RestraintFMQ · Traditional | Medi-Tech Intl. Corp. | 04/25/2011SE |
| K080448 | Centurion Protective Restraint, SCR SeriesFMQ · Traditional | Tri-State Hospital Supply Corp. | 08/28/2008SE |
| K013239 | Comfortcare Compression Support with Magnets Comfortcare Magnetic InsolesFMQ · Traditional | Med Gen, Inc. | 11/20/2001SE |
| K010818 | Infant Limb Holder, Models 306080 & 306081FMQ · Traditional | Skil-Care Corp. | 05/24/2001SE |
| K010644 | Cinch-Type Disposable Limb Holders, Model 912025FMQ · Traditional | Skil-Care Corp. | 05/18/2001SE |
| K991591 | Biothane Patient RestraintFMQ · Traditional | Bioplastics | 07/29/1999SE |
| K982178 | Vagabond Soft Restraint SystemFMQ · Traditional | Emergent Innovations, Ltd. | 01/26/1999SE |
| K980640 | Heelbo Waist and Chest VestFMQ · Traditional | Heelbo, Inc. | 05/01/1998SE |
| K972446 | Pedo Cush Pedo CuddleFMQ · Traditional | Cavity Free Kids, Inc. | 11/13/1997SE |
| K972046 | Full Body Restraint SystemFMQ · Traditional | Gillen Industries | 08/15/1997SE |
Questions and answers
When was Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002 cleared by the FDA?
Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002 (K081264) received a 510(k) decision of Substantially Equivalent on February 13, 2009, 284 days after the submission was received.
What is the product code of K081264?
The FDA product code is FMQ – Restraint, Protective, a Class I (low risk) device regulated under 21 CFR 880.6760.