510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K896947Substantially Equivalent

Chiropractic Massage Pillow

Intl. Pacific Industrial Corp. (USA), Inc., Coral Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896947 is the FDA 510(k) clearance record for CHIROPRACTIC MASSAGE PILLOW, a class I device, cleared for Intl. Pacific Industrial Corp. (Usa), Inc. on under FDA product code IRO (Vibrator, Therapeutic). FDA records list 2 510(k) clearances for Intl. Pacific Industrial Corp. (Usa), Inc., from to . As of , FDA records show no recalls naming K896947.

Clearance record

Decision date
Received
(20 days to decision)
Product code
IRO Vibrator, Therapeutic
Regulation
21 CFR 890.5975
Device class
Class I
Review panel
Physical Medicine
Applicant
Intl. Pacific Industrial Corp. (Usa), Inc. 10754 Wiles Rd., Coral Springs FL
Third party review
No

Clearances, product code IRO

Trailing 12 months

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

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