510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911195Substantially Equivalent

Dunlap Heat Pad

Home Healthcare Products, Inc., East Brunswick NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911195 is the FDA 510(k) clearance record for DUNLAP HEAT PAD, a class II device, cleared for Home Healthcare Products, Inc. on under FDA product code IRT (Pad, Heating, Powered). FDA records list 2 510(k) clearances for Home Healthcare Products, Inc., from to . As of , FDA records show no recalls naming K911195.

Clearance record

Decision date
Received
(147 days to decision)
Product code
IRT Pad, Heating, Powered
Regulation
21 CFR 890.5740
Device class
Class II
Review panel
Physical Medicine
Applicant
Home Healthcare Products, Inc. C/O Ntl Associates, Inc., East Brunswick NJ
Third party review
No

Clearances, product code IRT

Trailing 12 months

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

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