Holder, Infant Position
An infant position holder is a device used to safely and securely position infants during clinical procedures or transport, reducing the risk of movement or injury. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FRP, regulated under 21 CFR 880.5680, within the General Hospital medical specialty. This device is both exempt from GMP requirements and eligible for third-party 510(k) review.
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Basic Information
- Product Code
- FRP
- Device Class
- FDA class 1
- Regulation Number
- 880.5680
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K082367 | INFANT SLEEP BEANIE | Jun 12, 2009 | Substantially Equivalent | Life Innovations, LLC |
| K090284 | RES-Q INFANT WEDGE AND SLING | Jun 05, 2009 | Substantially Equivalent | Cr Enterprises, LLC |
| K062143 | KOZY COMFORT INFANT POSITIONER | Oct 24, 2006 | Substantially Equivalent | Alfred E Mann Inst. For Biomedical Engineering |
| K060986 | HEAD BED | Jul 11, 2006 | Substantially Equivalent | Steven H. Warnock, M.D. |
| K051300 | ROBIN HOOD VEST | Dec 08, 2005 | Substantially Equivalent | Kamber Corporation |
| K041996 | NIGHTFORM | Aug 03, 2004 | Substantially Equivalent | Plastic Surgery Solutions, LLC |
| K003511 | KENDALL-LTP TURNER SAVE-A-LINE | Jan 24, 2001 | Substantially Equivalent | The Ludlow Company LP |
| K943017 | NEONATAL RESTRAINT AND COMFORT SYSTEMS | Jan 19, 1995 | Substantially Equivalent | K.Bowmed, Inc. |
| K932636 | THE TUCKER SLING | Jan 26, 1994 | Substantially Equivalent | Tucker Designs, Ltd. |
| K905630 | INFANT REFLUX SLING | Mar 13, 1991 | Substantially Equivalent | Pedicraft, Inc. |
| K905629 | PEDICRAFT INFANT REFLUX WEDGE | Mar 13, 1991 | Substantially Equivalent | Pedicraft, Inc. |
| K882544 | CUDDLE UP PILLOW | Jan 31, 1989 | Substantially Equivalent | Ohio Medical Instrument Co., Inc. |
| K844176 | PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS | Jan 23, 1985 | Substantially Equivalent | Premie Comfort Products |
| K810609 | PEDIATRIC POSITION HOLDER | Mar 20, 1981 | Substantially Equivalent | Kaye Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.