Atlas FDA

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

Electro Med Supply, Inc. — Predicate Candidate Screening

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

120 daysmedian FDA review time
333 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K933368TENS-ITElectro Med Supply, Inc.1994-06-073330
K872207MS-108, POWERED MUSCLE STIMULATORElectro Med Supply, Inc.1987-10-061200
K872208MS-112, POWERED MUSCLE STIMULATORElectro Med Supply, Inc.1987-10-061200
K872206MD-104, POWERED MUSCLE STIMULATORElectro Med Supply, Inc.1987-10-061200
K862487MS-139 ELECTRONIC MUSCLE STIMULATORElectro Med Supply, Inc.1986-07-16160
K862486MS-159 ELECTRONIC MUSCLE STIMULATORElectro Med Supply, Inc.1986-07-16160
K862485MS-179 ELECTRONIC MUSCLE STIMULATORElectro Med Supply, Inc.1986-07-16160
K854801MS-189 MUSCLE STIMULATORElectro Med Supply, Inc.1986-03-271150

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