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Goniometer, Nonpowered

Page Type
Product Code
Regulation Medical Specialty
Orthopedic
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
888.1520
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 888.1520 Nonpowered goniometer

§ 888.1520 Nonpowered goniometer.

(a) Identification. A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.

(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 § 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]

Goniometer, Nonpowered

Page Type
Product Code
Regulation Medical Specialty
Orthopedic
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
888.1520
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 888.1520 Nonpowered goniometer

§ 888.1520 Nonpowered goniometer.

(a) Identification. A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.

(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 § 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]