Last synced on 2 December 2022 at 11:04 pm

Analyzer, Body Composition, Exempt

Page Type
Product Code
Definition
This product code is the class II exempt counterpart of MNW, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Physical State
Exemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition.
Technical Method
This product code is the class II exempt counterpart of MNW, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Target Area
This product code is the class II exempt counterpart of MNW, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Regulation Medical Specialty
Cardiovascular
Review Panel
Gastroenterology and Urology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
870.2770
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 870.2770 Impedance plethysmograph

§ 870.2770 Impedance plethysmograph.

(a) Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

(b) Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]

Analyzer, Body Composition, Exempt

Page Type
Product Code
Definition
This product code is the class II exempt counterpart of MNW, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Physical State
Exemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition.
Technical Method
This product code is the class II exempt counterpart of MNW, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Target Area
This product code is the class II exempt counterpart of MNW, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Regulation Medical Specialty
Cardiovascular
Review Panel
Gastroenterology and Urology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
870.2770
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 870.2770 Impedance plethysmograph

§ 870.2770 Impedance plethysmograph.

(a) Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

(b) Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]