21 CFR 890.5050 — Utensil, Homemaking
Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5050
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IKW | Utensil, Homemaking | 1 | 12 | |
| IKX | Aid, Transfer | 1 | 18 | |
| ILC | Utensil, Eating | 1 | 32 | |
| ILD | Adaptor, Dressing | 1 | 14 | |
| ILS | Adaptor, Hygiene | 1 | 31 | |
| ILT | Adaptor, Recreational | 1 | 7 | |
| ILW | Adaptor, Grooming | 1 | 7 | |
| IQG | Adaptor, Holder, Syringe | 1 | 3 | |
| NXB | Dispenser, Solid Medication | 1 | 3 | |
| NXQ | Reminder, Medication | 1 | 2 | |
| OAG | Garment, Storage, Peritoneal Dialysis Catheter | 1 | 0 | |
| OIZ | Foot Examination Tool For Inflammatory Changes | 1 | 2 | |
| OJL | Insulin Vial Protector/Holder | 1 | 0 | |
| PCM | Portable Liquid Oxygen Unit Stand | 1 | 1 | |
| QTC | Adult Portable Bed Rails For Medical Purposes | 1 | 0 |
