510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K821836Substantially Equivalent

Pregnancy (W) Edge

Body Therapeutics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821836 is the FDA 510(k) clearance record for PREGNANCY (W) EDGE, a class I device, cleared for Body Therapeutics, Inc. on under FDA product code QSB (Orthosis, Truncal, Pregnancy). FDA's definition for product code QSB reads: "Provide abdominal and back support during pregnancy". FDA records list 5 510(k) clearances for Body Therapeutics, Inc., from to . As of , FDA records show no recalls naming K821836.

Clearance record

Decision date
Received
(38 days to decision)
Product code
QSB Orthosis, Truncal, Pregnancy
Regulation
21 CFR 890.3490
Device class
Class I
Review panel
Physical Medicine
Applicant
Body Therapeutics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code QSB

Trailing 12 months

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

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