510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031077Substantially Equivalent

Vectra Epr System and Intelect Epr System

Chattanooga Group, Inc., Hixson TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031077 is the FDA 510(k) clearance record for VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM, a class II device, cleared for Chattanooga Group on under FDA product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat). FDA records list 81 510(k) clearances for Chattanooga Group, from to . As of , FDA records show 17 recalls naming K031077.

Clearance record

Decision date
Received
(251 days to decision)
Product code
IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5860
Device class
Class II
Review panel
Physical Medicine
Applicant
Chattanooga Group 4717 Adams Rd., Hixson TN
510(k) summary
Statement
Third party review
No

Clearances, product code IMG

Trailing 12 months

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

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