FDA applicant
Tissue Regeneration Technologies, LLC Dba AS Softwave Trt
FDA records 1 decision for Tissue Regeneration Technologies, LLC Dba AS Softwave Trt (Woodstock, GA) in 2022: 1 510(k) clearance. All are in product code ISA (Massager, Therapeutic, Electric). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tissue Regeneration Technologies, LLC Dba AS Softwave Trt’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Tissue Regeneration Technologies, LLC…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Tissue”
FDA records each applicant name separately; these may or may not be the same firm.