Last synced on 2 December 2022 at 11:04 pm

Field Generator Positioning Device

Page Type
Product Code
Definition
An accessory or a group of accessories that operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, to manually position the Field Generator of a Navigation System in proximity to a patient.
Physical State
Mounting arms, holders, stands, and clamps that fix a Field Generator in a desired position
Technical Method
Non-electrical, multi-joint mechanical arms intended for holding existing medical equipment by using a mechanical interface
Target Area
Body
Regulation Medical Specialty
Neurology
Review Panel
Ear, Nose, Throat
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
882.4565
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QLV is linked to regulation 21CFR882.4565, which does not seem to exist yet. It may be pending at the moment.

Field Generator Positioning Device

Page Type
Product Code
Definition
An accessory or a group of accessories that operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, to manually position the Field Generator of a Navigation System in proximity to a patient.
Physical State
Mounting arms, holders, stands, and clamps that fix a Field Generator in a desired position
Technical Method
Non-electrical, multi-joint mechanical arms intended for holding existing medical equipment by using a mechanical interface
Target Area
Body
Regulation Medical Specialty
Neurology
Review Panel
Ear, Nose, Throat
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
882.4565
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QLV is linked to regulation 21CFR882.4565, which does not seem to exist yet. It may be pending at the moment.