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
K831002Substantially Equivalent

Tpg 1000

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

K831002 is the FDA 510(k) clearance record for TPG 1000, a class I device, cleared for Physical Diagnostics, Inc. on under FDA product code KQZ (Component, Traction, Non-Invasive). FDA records list one 510(k) clearance for Physical Diagnostics, Inc. As of , FDA records show no recalls naming K831002.

Clearance record

Decision date
Received
(87 days to decision)
Product code
KQZ Component, Traction, Non-Invasive
Regulation
21 CFR 888.5890
Device class
Class I
Review panel
Orthopedic
Applicant
Physical Diagnostics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KQZ

Trailing 12 months

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

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