FRP · Holder, Infant Position
General Hospital · 21 CFR 880.5680 · Class 1
Overview
| Product Code | FRP |
|---|---|
| Device Name | Holder, Infant Position |
| Regulation | 21 CFR 880.5680 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
| 3rd-Party Reviewable | Yes |
Identification
A pediatric position holder is a device used to hold an infant or a child in a desired position for therapeutic or diagnostic purposes, e.g., in a crib under a radiant warmer, or to restrain a child while an intravascular injection is administered.
Classification Rationale
Class I (general controls). Except when the device is an infant positioner for prescription use in highly monitored settings or an infant sleep position holder, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. The device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K082367 | INFANT SLEEP BEANIE | Life Innovations, LLC | Jun 12, 2009 | SESE |
| K090284 | RES-Q INFANT WEDGE AND SLING | Cr Enterprises, LLC | Jun 5, 2009 | SESE |
| K062143 | KOZY COMFORT INFANT POSITIONER | Alfred E Mann Inst. For Biomedical Engineering | Oct 24, 2006 | SESE |
| K060986 | HEAD BED | Steven H. Warnock, M.D. | Jul 11, 2006 | SESE |
| K051300 | ROBIN HOOD VEST | Kamber Corporation | Dec 8, 2005 | SESE |
| K041996 | NIGHTFORM | Plastic Surgery Solutions, LLC | Aug 3, 2004 | SESE |
| K003511 | KENDALL-LTP TURNER SAVE-A-LINE | The Ludlow Company LP | Jan 24, 2001 | SESE |
| K943017 | NEONATAL RESTRAINT AND COMFORT SYSTEMS | K.Bowmed, Inc. | Jan 19, 1995 | SESE |
| K932636 | THE TUCKER SLING | Tucker Designs, Ltd. | Jan 26, 1994 | SESE |
| K905630 | INFANT REFLUX SLING | Pedicraft, Inc. | Mar 13, 1991 | SESE |
| K905629 | PEDICRAFT INFANT REFLUX WEDGE | Pedicraft, Inc. | Mar 13, 1991 | SESE |
| K882544 | CUDDLE UP PILLOW | Ohio Medical Instrument Co., Inc. | Jan 31, 1989 | SESE |
| K844176 | PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS | Premie Comfort Products | Jan 23, 1985 | SESE |
| K810609 | PEDIATRIC POSITION HOLDER | Kaye Products, Inc. | Mar 20, 1981 | SESE |
Top Applicants
- Pedicraft, Inc. — 2 clearances
- Alfred E Mann Inst. For Biomedical Engineering — 1 clearance
- Cr Enterprises, LLC — 1 clearance
- K.Bowmed, Inc. — 1 clearance
- Kamber Corporation — 1 clearance
