ITG · Bandage, Cast
Physical Medicine · 21 CFR 890.3025 · Class 1
Overview
| Product Code | ITG |
|---|---|
| Device Name | Bandage, Cast |
| Regulation | 21 CFR 890.3025 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.
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 the limitations in § 890.9. The device is also 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 (20 of 37)
Showing 20 most recent of 37 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K873111 | CONFORMA(TM) PLASTER BANDAGES | The Kendal Co. | Oct 9, 1987 | SESE |
| K862115 | DEKNA BAND KIT | Deknatel, Inc. | Aug 19, 1986 | SESE |
| K842573 | T.P.G. CAST TAPE | The Poly Group, Inc. | Aug 10, 1984 | SESE |
| K840416 | HEXCELITE | Hexcel Medical | Mar 23, 1984 | SESE |
| K833732 | NON WETTING UNDERCAST PADDING | American Medical Disposable, Inc. | Dec 12, 1983 | SESE |
| K832992 | SOFFBAN ORTHOPEDIC PADDING | Smith & Nephew, Inc. | Nov 14, 1983 | SESE |
| K832237 | ORTHOPEDIC CASTING TAPE MAXCAST | Cutter Laboratories, Inc. | Aug 16, 1983 | SESE |
| K830650 | SUPPORT PRODUCTS EXAMPLE PROSET CAST | Isopedix Corp. | Jul 7, 1983 | SESE |
| K831492 | YESONA PLASTER OF PARIS BANDAGE | Watson Phillips Y Cia. Sucs., S.A. DE C.V. | Jun 30, 1983 | SESE |
| K820890 | URETHANE ORTHOPAEDIC CASTING TAPE | Hexcel Medical | Jun 23, 1982 | SESE |
| K820155 | SPECIALIST CAST PADDING | Stan-Pak Ent. | Feb 12, 1982 | SESE |
| K820140 | WEBRIL CAST PADDING | Stan-Pak Ent. | Feb 12, 1982 | SESE |
| K813052 | ULTRACAST WATERLESS SYNTHETIC RESIN CAST | Zimmer, Inc. | Feb 4, 1982 | SESE |
| K813219 | CARAFLEX ELASTIC POLYMER PLASTER BANDA | Carapace, Inc. | Dec 17, 1981 | SESE |
| K811754 | CRYSTONA | Smith & Nephew, Inc. | Jul 20, 1981 | SESE |
| K811164 | URETHANE ORTHOPAEDIC CASTING TAPE | Hexcel Medical | May 27, 1981 | SESE |
| K810877 | ORTHOSIS BANDAGES | Ortho-Cast, Inc. | Apr 17, 1981 | SESE |
| K810111 | CELLONA PLASTER VARNISH | Secol Co. | Feb 4, 1981 | SESE |
| K802792 | CELLONA | Secol Co. | Dec 10, 1980 | SESE |
| K802796 | CELLAMIN | Secol Co. | Nov 24, 1980 | SESE |
Top Applicants
- Hexcel Medical — 4 clearances
- Johnson & Johnson Professionals, Inc. — 3 clearances
- Secol Co. — 3 clearances
- Solar Laboratories, Inc. — 3 clearances
- Cutter Laboratories, Inc. — 2 clearances
