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Title 21 Part 880 → Subpart G → §880.6050

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart G → §880.6050

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart G → §880.6050

e-CFR data is current as of September 12, 2019

Title 21Chapter ISubchapter HPart 880Subpart G → §880.6050


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices


§880.6050   Ice bag.

(a) 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.

(b) Classification. 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 system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001]