BTX · Board, Arm (With Cover), Sterile
General, Plastic Surgery · 21 CFR 878.3910 · Class 1
Overview
| Product Code | BTX |
|---|---|
| Device Name | Board, Arm (With Cover), Sterile |
| Regulation | 21 CFR 878.3910 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. If the device is not labeled or otherwise represented as sterile, it 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 (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K935098 | BABY BOARD | Sentry Medical Products, Inc. | Feb 15, 1994 | SESE |
| K900175 | 4/1 ARMBOARD | Infection Control Products, Inc. | Jan 24, 1990 | SESE |
| K884838 | ALLEN PRONE ARMBOARD | Edgewater Medical Systems, Inc. | Dec 15, 1988 | SESE |
| K882524 | UNIVERSALLY ADJUSTABLE ARMBOARD | Karlin Technology, Inc. | Jul 8, 1988 | SESE |
| K881292 | ALLEN LATERAL ARMBOARD | Edgewater Medical Systems, Inc. | Apr 7, 1988 | SESE |
| K864670 | BOARD, ARM (WITH COVER) | Anago, Inc. | Jan 12, 1987 | SESE |
| K833664 | ARMBOARD AND THE BOARD | Rick Robbin & Frederick Auerbach | Dec 27, 1983 | SESE |
| K830018 | SAFE-T ARM BOARD | Harvey A. Turner, M.D. | Jan 26, 1983 | SESE |
| K823412 | ARM BOARD W/I.V COVERING | Sage Products, Inc. | Dec 15, 1982 | SESE |
| K811419 | SPRIO-LOOP | Datamed, Inc. | Jun 12, 1981 | SESE |
| K792147 | ARM SHIELD FOR ANESTHESIA | Medical Innovations Corp. | Dec 6, 1979 | SESE |
| K781233 | IV ARMBOARDS | Fibre Formations, Inc. | Aug 14, 1978 | SESE |
| K770391 | COVER, ARMBOARD, DISPOSABLE | Precept, Inc. | Mar 7, 1977 | SESE |
Top Applicants
- Edgewater Medical Systems, Inc. — 2 clearances
- Sentry Medical Products, Inc. — 1 clearance
- Sage Products, Inc. — 1 clearance
- Rick Robbin & Frederick Auerbach — 1 clearance
- Precept, Inc. — 1 clearance
