510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213120Substantially Equivalent

OW100S (model OW100S-US)

Tissue Regeneration Technologies, LLC dba AS Softwave Trt, Woodstock GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213120 is the FDA 510(k) clearance record for OW100S (model OW100S-US), a class I device, cleared for Tissue Regeneration Technologies, LLC Dba AS Softwave Trt on under FDA product code ISA (Massager, Therapeutic, Electric). FDA records list one 510(k) clearance for Tissue Regeneration Technologies, LLC Dba AS Softwave Trt. As of , FDA records show no recalls naming K213120.

Clearance record

Decision date
Received
(380 days to decision)
Product code
ISA Massager, Therapeutic, Electric
Regulation
21 CFR 890.5660
Device class
Class I
Review panel
Physical Medicine
Applicant
Tissue Regeneration Technologies, LLC Dba AS Softwave Trt 251 Heritage Walk, Woodstock GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ISA

Trailing 12 months

FDA records hold no clearances under product code ISA in the trailing twelve months.

FDA records show no clearances under product code ISA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ISA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260