510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902948Substantially Equivalent

Comfortron II (TENS)

M. D. Products, Ocala FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902948 is the FDA 510(k) clearance record for COMFORTRON II (TENS), cleared for M. D. Products on under FDA product code LWM (Device, Electrical Dental Anesthesia). FDA records list 3 510(k) clearances for M. D. Products, from to . As of , FDA records show no recalls naming K902948.

Clearance record

Decision date
Received
(165 days to decision)
Product code
LWM Device, Electrical Dental Anesthesia
Device class
Unclassified
Review panel
Unknown
Applicant
M. D. Products 2137 SE Fort King, Ocala FL
Third party review
No

Clearances, product code LWM

Trailing 12 months

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

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