Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Rehab Medical Specialties, Inc. · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K881470SOKEN PLUS(TM) ELECTRONIC MUSCLE STIMULATORRehab Medical Specialties, Inc.1989-03-103370
K873125SOKEN(TM) ELECTRONIC MUSCLE STIMULATORRehab Medical Specialties, Inc.1987-12-311430
K834092MULTIPLE SOKEN 3 ELECTRON-MUSCLE STIMRehab Medical Specialties, Inc.1983-12-20220

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