510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871006Substantially Equivalent

Edcool and Edcool Jr. Instant Cold Pack

Advantage Credit Services, Inc., Kansas City MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871006 is the FDA 510(k) clearance record for EDCOOL AND EDCOOL JR. INSTANT COLD PACK, a class I device, cleared for Advantage Credit Services, Inc. on under FDA product code IMP (Cushion, Wheelchair). FDA records list 4 510(k) clearances for Advantage Credit Services, Inc., from to . As of , FDA records show no recalls naming K871006.

Clearance record

Decision date
Received
(12 days to decision)
Product code
IMP Cushion, Wheelchair
Regulation
21 CFR 890.3920
Device class
Class I
Review panel
Physical Medicine
Applicant
Advantage Credit Services, Inc. P.O. Box 768, Kansas City MO
Third party review
No

Clearances, product code IMP

Trailing 12 months

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

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