KYR · Bag, Ice
General Hospital · 21 CFR 880.6050 · Class 1
Overview
| Product Code | KYR |
|---|---|
| Device Name | Bag, Ice |
| Regulation | 21 CFR 880.6050 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
An ice bag is a device intended for medical purposes that is in the form of a container intended to be filled with ice that is used to apply dry cold therapy to an area of the body. The device may include a holder that keeps the bag in place against an external area of the patient.
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 § 880.9. If the device is not labeled or otherwise represented as sterile, it 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K833872 | SAV-A-LIMB | Sil-Med Corp. | Feb 4, 1984 | SESE |
| K810653 | VINYL ICE BAG | First Industries, Inc. | Mar 27, 1981 | SESE |
| K780608 | ICE BAG, VINYL | Abco Dealers, Inc. | Jun 6, 1978 | SESE |
| K760951 | DEVON COOL FACE | Devon Industries, Inc. | Dec 30, 1976 | SESE |
Top Applicants
- Abco Dealers, Inc. — 1 clearance
- Devon Industries, Inc. — 1 clearance
- First Industries, Inc. — 1 clearance
- Sil-Med Corp. — 1 clearance
