Ultra Care Vest Style Body Holder, Small (24455-010,020,030,040,24456-010,020,030,040)
FDA 510(k) K963561 · Tecnol Medical Products, Inc.
510(k) numberK963561
Submission
- Device name
- Ultra Care Vest Style Body Holder, Small (24455-010,020,030,040,24456-010,020,030,040)
- Applicant
- Tecnol Medical Products, Inc.
Fort Worth, TX, US - Received
- September 5, 1996
- Decision date
- November 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|---|
| K110377 | Protective RestraintFMQ · Traditional | Medi-Tech Intl. Corp. | 04/25/2011SE |
| 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 |
|---|---|---|
| K974068 | PFR95 Particulate Filter Respirator and Surgical Mask Regular Size, PFR95 Particulate…MSH · Traditional | 12/22/1997SE |
| K970448 | PCM 2000; Isolair Apr Model 2735MSH · Traditional | 04/30/1997SE |
| K963564 | Personal Limb Holder (24444-200,300,24444-KIT)FMQ · Traditional | 11/22/1996SE |
| K963559 | Wrparound Limb Holder (24446,24446-350,24447-010,24449-010)FMQ · Traditional | 11/22/1996SE |
| K963552 | Quick Release Limb Holder (24442,24442-050,24442-350)FMQ · Traditional | 11/22/1996SE |
| K963773 | 24457-010 Secure All Pelvic HOLDER/24458-010 Secure All Body BeltFMQ · Traditional | 11/21/1996SE |
| K963563 | Ultracare Vest Style Body Holder with Safety Sleeves, SMALL(24454-010,020,030,040,015,025…FMQ · Traditional | 11/21/1996SE |
| K963557 | System 2 Zippered Body Holder, Small/Medium 24453-010,24453-020,24453-030FMQ · Traditional | 11/21/1996SE |
| K963556 | Secure-All 1-PIECE Body Holder, Small/Medium (24451-010,020,24452-010,020,030)FMQ · Traditional | 11/21/1996SE |
| K963554 | 24448-010 Secure-All Finger Control MittFMQ · Traditional | 11/21/1996SE |
Questions and answers
When was Ultra Care Vest Style Body Holder, Small (24455-010,020,030,040,24456-010,020,030,040) cleared by the FDA?
Ultra Care Vest Style Body Holder, Small (24455-010,020,030,040,24456-010,020,030,040) (K963561) received a 510(k) decision of Substantially Equivalent on November 21, 1996, 77 days after the submission was received.
What is the product code of K963561?
The FDA product code is FMQ – Restraint, Protective, a Class I (low risk) device regulated under 21 CFR 880.6760.