510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K953442Substantially Equivalent for Some Indications

Restore, Thermacells (Hot Pack I)

Neal Dunning Assoc., Inc., Bethesda MD / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K953442 is the FDA 510(k) clearance record for RESTORE, THERMACELLS (HOT PACK I), a class I device, cleared for Neal Dunning Assoc., Inc. on under FDA product code IMD (Pack, Hot Or Cold, Disposable). FDA records list one 510(k) clearance for Neal Dunning Assoc., Inc. As of , FDA records show no recalls naming K953442.

Clearance record

Decision date
Received
(106 days to decision)
Product code
IMD Pack, Hot Or Cold, Disposable
Regulation
21 CFR 890.5710
Device class
Class I
Review panel
Physical Medicine
Applicant
Neal Dunning Assoc., Inc. 8309 Bryant Dr., Bethesda MD
Third party review
No

Clearances, product code IMD

Trailing 12 months

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

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