510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940621Substantially Equivalent for Some Indications

Pro-Shiatsu Portable Massager

Westminster International Co., Inc., Atlanta GA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K940621 is the FDA 510(k) clearance record for PRO-SHIATSU PORTABLE MASSAGER, a class I device, cleared for Westminster International Co., Inc. on under FDA product code ISA (Massager, Therapeutic, Electric). FDA records list 2 510(k) clearances for Westminster International Co., Inc. As of , FDA records show no recalls naming K940621.

Clearance record

Decision date
Received
(128 days to decision)
Product code
ISA Massager, Therapeutic, Electric
Regulation
21 CFR 890.5660
Device class
Class I
Review panel
Physical Medicine
Applicant
Westminster International Co., Inc. 436 Armour Cir.,NE, Atlanta GA
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