Restraints (Vests and Jackets)
FDA 510(k) K971536 · E.M. Adams Co., Inc.
510(k) numberK971536
Submission
- Device name
- Restraints (Vests and Jackets)
- Applicant
- E.M. Adams Co., Inc.
Fort Pierce, FL, US - Received
- April 28, 1997
- Decision date
- July 1, 1997
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K971948 | Patient RestraintFMQ · Traditional | 08/06/1997SE |
| K905173 | Splash GuardKYZ · Traditional | 04/25/1991SE |
| K910468 | Sterile Disposable Drape(S)FZI · Traditional | 03/21/1991SE |
| K873978 | Disposable Bipolar ForcepsGEN · Traditional | 11/23/1987SE |
| K850063 | Instrument Pocket · Traditional | 02/21/1985SE |
| K843724 | I.V. Start Kit & Obstetrical KitKKX · Traditional | 01/10/1985SE |
| K843783 | Wet PackEFQ · Traditional | 12/19/1984SE |
| K843782 | Dry TrayEFQ · Traditional | 12/13/1984SE |
| K843723 | Sterile Instrument Trays-VariousFSM · Traditional | 10/23/1984SE |
| K843115 | Sterile Solution BowlKDD · Traditional | 09/07/1984SE |
Questions and answers
When was Restraints (Vests and Jackets) cleared by the FDA?
Restraints (Vests and Jackets) (K971536) received a 510(k) decision of Substantially Equivalent on July 1, 1997, 64 days after the submission was received.
What is the product code of K971536?
The FDA product code is FMQ – Restraint, Protective, a Class I (low risk) device regulated under 21 CFR 880.6760.