Product code FRP
- Device name
- Holder, Infant Position
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.5680
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K082367 | INFANT SLEEP BEANIE | Life Innovations, LLC | 2009-06-12 |
| K090284 | RES-Q INFANT WEDGE AND SLING | Cr Enterprises, LLC | 2009-06-05 |
| K062143 | KOZY COMFORT INFANT POSITIONER | Alfred E Mann Inst. For Biomedical Engineering | 2006-10-24 |
| K060986 | HEAD BED | Steven H. Warnock, M.D. | 2006-07-11 |
| K051300 | ROBIN HOOD VEST | Kamber Corporation | 2005-12-08 |
| K041996 | NIGHTFORM | Plastic Surgery Solutions, LLC | 2004-08-03 |
| K003511 | KENDALL-LTP TURNER SAVE-A-LINE | The Ludlow Company LP | 2001-01-24 |
| K943017 | NEONATAL RESTRAINT AND COMFORT SYSTEMS | K.Bowmed, Inc. | 1995-01-19 |
| K932636 | THE TUCKER SLING | Tucker Designs, Ltd. | 1994-01-26 |
| K905629 | PEDICRAFT INFANT REFLUX WEDGE | Pedicraft, Inc. | 1991-03-13 |
| K905630 | INFANT REFLUX SLING | Pedicraft, Inc. | 1991-03-13 |
| K882544 | CUDDLE UP PILLOW | Ohio Medical Instrument Co., Inc. | 1989-01-31 |
| K844176 | PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS | Premie Comfort Products | 1985-01-23 |
| K810609 | PEDIATRIC POSITION HOLDER | Kaye Products, Inc. | 1981-03-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04260764840557 | MedibinoNEO ring – TG PUR Gel - Size L - PU 6 | Kluba Medical GmbH | 2024-09-06 |
| 04260764840571 | MedibinoNEO ring – TG PUR Gel - Size S - PU6 | Kluba Medical GmbH | 2024-09-06 |
| 04260764840649 | MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size L - PU50 | Kluba Medical GmbH | 2024-09-06 |
| 04260764840656 | MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU50 | Kluba Medical GmbH | 2024-09-06 |
| 04260764840663 | MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size S - PU50 | Kluba Medical GmbH | 2024-09-06 |
| 04260764840670 | MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50 | Kluba Medical GmbH | 2024-09-06 |
| 04260764840687 | MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50 | Kluba Medical GmbH | 2024-09-06 |
| 04260764840694 | MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50 | Kluba Medical GmbH | 2024-09-06 |
| 04260764840564 | MedibinoNEO ring – TG PUR Gel - Size M - PU6 | Kluba Medical GmbH | 2024-09-06 |
| 04260764840724 | MedibinoNEO ring – TG PUR Gel - Size S - PU6 | Kluba Medical GmbH | 2024-09-06 |
| 04260764840809 | MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU50 | Kluba Medical GmbH | 2024-09-06 |
| 04260764840847 | MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50 | Kluba Medical GmbH | 2024-09-06 |
| 00610570004812 | DANNY SLING 10-18 LBS | Bird & Cronin, LLC | 2022-08-20 |
| 00610570004850 | DANNY SLING 2-5 LBS | Bird & Cronin, LLC | 2022-08-20 |
| 00610570006755 | DANNY SLING 5-9 LBS | Bird & Cronin, LLC | 2022-08-20 |
| 00610570007301 | KERRY KUDDLER 18-40 LBS | Bird & Cronin, LLC | 2022-08-20 |