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Portable Liquid Oxygen Unit Stand

Page Type
Product Code
Definition
To assist the user with refilling a portable liquid oxygen tank from a reservoir unit by holding the portable liquid oxygen tank in an upright position.
Physical State
Portable Liquid Oxygen Unit
Technical Method
physically maintains the portable liquid oxygen tank in an upright position
Target Area
portable liquid oxygen tanks and reservoir units
Regulation Medical Specialty
Physical Medicine
Review Panel
Anesthesiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
890.5050
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 890.5050 Daily activity assist device

§ 890.5050 Daily activity assist device.

(a) 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.

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

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]

Portable Liquid Oxygen Unit Stand

Page Type
Product Code
Definition
To assist the user with refilling a portable liquid oxygen tank from a reservoir unit by holding the portable liquid oxygen tank in an upright position.
Physical State
Portable Liquid Oxygen Unit
Technical Method
physically maintains the portable liquid oxygen tank in an upright position
Target Area
portable liquid oxygen tanks and reservoir units
Regulation Medical Specialty
Physical Medicine
Review Panel
Anesthesiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
890.5050
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 890.5050 Daily activity assist device

§ 890.5050 Daily activity assist device.

(a) 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.

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

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]