{"data":{"id":"us/21-cfr-882.4565","jurisdiction":"us","citation":"21 CFR 882.4565","heading":"Field generator positioning device.","body":"(a) Identification. A field generator positioning device is a manual, mechanical device intended to position the field generator of an electromagnetic based stereotaxic navigation system in proximity to a patient. The device may operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, by using a mechanical interface.\n(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 § 882.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 882—NEUROLOGICAL DEVICES","Subpart E—Neurological Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"bae371a9b5ac9c870a5f2fb7e4d7f1721fad447cd9078f2a861d21441aa94204","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-882.4560","next":"us/21-cfr-882.4600"},"notice":"GroundRules: Original legal text. Not legal advice."}