Alimed Positioning 7 Safety Straps (Three Types), Universal Cr/Mri Wide Body Strap, Universal CT Scanner Strap (2 Sizes)
FDA 510(k) K963528 · Alimed, Inc.
510(k) numberK963528
Submission
- Device name
- Alimed Positioning 7 Safety Straps (Three Types), Universal Cr/Mri Wide Body Strap, Universal CT Scanner Strap (2 Sizes)
- Applicant
- Alimed, Inc.
Dedham, MA, US - Received
- September 4, 1996
- Decision date
- October 29, 1996
- 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
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|---|---|---|---|
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| K081264 | Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002FMQ · Traditional | Children'S Health First, Inc. | 02/13/2009SE |
| 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 |
More from Cavity Free Kids, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K963527 | Universal Econo-Strap, Qualcraft Universal StrapsFMQ · Traditional | 10/31/1996SE |
| K963526 | Strap WedgeFMQ · Traditional | 10/28/1996SE |
| K920487 | Mini VibratorIRO · Traditional | 02/18/1992SE |
| K840156 | Protecta Coat SpongesIZZ · Traditional | 03/23/1984SE |
| K822650 | Super DonutKME · Traditional | 09/30/1982SE |
| K822651 | Total Finger Flexion SplintILH · Traditional | 09/17/1982SE |
| K820516 | Arterial Canalization DeviceDQY · Traditional | 04/15/1982SE |
| K820517 | Constructa Foam · Traditional | 03/10/1982SE |
| K801743 | Plastazote ShoeKNP · Traditional | 08/07/1980SE |
| K791189 | Echo Cardiogram PadFNJ · Traditional | 07/17/1979SE |
Questions and answers
When was Alimed Positioning 7 Safety Straps (Three Types), Universal Cr/Mri Wide Body Strap, Universal CT Scanner Strap (2 Sizes) cleared by the FDA?
Alimed Positioning 7 Safety Straps (Three Types), Universal Cr/Mri Wide Body Strap, Universal CT Scanner Strap (2 Sizes) (K963528) received a 510(k) decision of Substantially Equivalent on October 29, 1996, 55 days after the submission was received.
What is the product code of K963528?
The FDA product code is FMQ – Restraint, Protective, a Class I (low risk) device regulated under 21 CFR 880.6760.