510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813098Substantially Equivalent

TENS Device

Staodynamics, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813098 is the FDA 510(k) clearance record for TENS DEVICE, cleared for Staodynamics, Inc. on . FDA records list 14 510(k) clearances for Staodynamics, Inc., from to . As of , FDA records show no recalls naming K813098.

Clearance record

Decision date
Received
(17 days to decision)
Review panel
Unknown
Applicant
Staodynamics, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No