510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830259Substantially Equivalent

Protet Soap & Wash Mitt

Ritmed, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830259 is the FDA 510(k) clearance record for PROTET SOAP & WASH MITT, a class I device, cleared for Ritmed, Inc. on under FDA product code GED (Brush, Dermabrasion, Manual). FDA records list 22 510(k) clearances for Ritmed, Inc., from to . As of , FDA records show no recalls naming K830259.

Clearance record

Decision date
Received
(104 days to decision)
Product code
GED Brush, Dermabrasion, Manual
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Ritmed, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GED

Trailing 12 months

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

FDA records show no clearances under product code GED in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GED, 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