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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

General Theraphysical, Inc. — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

64 daysmedian FDA review time
64 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K781317ULTRASONIC THERAPY APPARATUS, 407General Theraphysical, Inc.1978-10-03640
K781319THERAPY APPAR. 422 INTERFERENTIALGeneral Theraphysical, Inc.1978-10-03640
K781318DYNATRON 406 ELECTROTHERAPY APPARATUSGeneral Theraphysical, Inc.1978-10-03640
K781315MUSCLE STIMULATION APPARATUSGeneral Theraphysical, Inc.1978-10-03640
K781314THERAPY UNIT & ELECTRODIAG.General Theraphysical, Inc.1978-10-03640
K781316PULSED AND CONTINUOUS SHORTWAVE APPAR.General Theraphysical, Inc.1978-09-27580
K781320SHORTWAVE THERAPY APPAR. CURAMED 401General Theraphysical, Inc.1978-09-27580

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda