ILC · Utensil, Eating
Physical Medicine · 21 CFR 890.5050 · Class 1
Overview
| Product Code | ILC |
|---|---|
| Device Name | Utensil, Eating |
| Regulation | 21 CFR 890.5050 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.
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. If the device is not labeled or otherwise represented as sterile, 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 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K833177 | GLOSSECTOMY FEEDING SPOONS | Maddak, Inc. | Oct 31, 1983 | SESE |
| K830854 | COLLAPSABLE LAVATORY SEAT HEIGHTENER | Lic-Orthion | Apr 5, 1983 | SESE |
| K830851 | BATH TUB SEAT & BATH BOARD | Lic-Orthion | Apr 5, 1983 | SESE |
| K823594 | PLASTIC BUILT-UP HANDLE EATING UTENSILS | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K821643 | EATING UTENSILS | Fred Sammons, Inc. | Jun 11, 1982 | SESE |
| K813630 | BK-1129 BOTTLE STRAW | Fred Sammons, Inc. | Jan 19, 1982 | SESE |
| K812346 | ALUMINUM SCOOP DISK | Fred Sammons, Inc. | Sep 11, 1981 | SESE |
| K811488 | FEEDING AID KIT | Fred Sammons, Inc. | Jun 12, 1981 | SESE |
| K810455 | EATING UTENSILS | Fred Sammons, Inc. | Mar 4, 1981 | SESE |
| K801706 | BK-1426-00-01 STONYBROOK/HI-WALL PLATE | Fred Sammons, Inc. | Aug 7, 1980 | SESE |
| K801705 | BK-1424 INNER LIP PLATE, CERAMIC | Fred Sammons, Inc. | Aug 7, 1980 | SESE |
| K800019 | BK-1544 BE OK SCOOP DISK | Fred Sammons, Inc. | Jan 21, 1980 | SESE |
| K790170 | BK-1472 SPATULA SPOON | Fred Sammons, Inc. | Feb 13, 1979 | SESE |
| K781196 | UTENSILS, WEIGHTED | Fred Sammons, Inc. | Jul 31, 1978 | SESE |
| K781193 | KNIFE, LARGE HANDLE | Fred Sammons, Inc. | Jul 31, 1978 | SESE |
| K781192 | KNIFE, ROCKER, SLOTTED HANDLE | Fred Sammons, Inc. | Jul 31, 1978 | SESE |
| K781191 | SPORKS, PLASTIC, DISP. | Fred Sammons, Inc. | Jul 31, 1978 | SESE |
| K771274 | QUADRIPLEGIC MEAT KNIFE | Fred Sammons, Inc. | Jul 21, 1977 | SESE |
| K770169 | BEESON AUTOMADDAK FEEDER | Techhnilab Instruments, Inc. | Jan 28, 1977 | SESE |
| K761113 | BUILT-UP HANDLE UTENSILS | Fred Sammons, Inc. | Dec 2, 1976 | SESE |
Top Applicants
- Fred Sammons, Inc. — 28 clearances
- Lic-Orthion — 2 clearances
- Maddak, Inc. — 1 clearance
- Techhnilab Instruments, Inc. — 1 clearance
