Comfortron II (TENS)

FDA 510(k) K902948 · M. D. Products

Substantially Equivalent

510(k) numberK902948

Submission

Device name
Comfortron II (TENS)
Applicant
M. D. Products
Ocala, FL, US
Received
July 5, 1990
Decision date
December 17, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LWM – Device, Electrical Dental Anesthesia
Device class
Unclassified

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K193570Dental Pain EraserLWM · Special Synapse Dental01/17/2020SE
K192429Dental Pain EraserLWM · Traditional Synapse Dental01/14/2020SE
K182947Dental Pain EraserLWM · Traditional Synapse Dental, LLC03/26/2019SE
K011001Team-Up TM Dental Electronic Anesthesia SystemLWM · Traditional Satelec06/07/2001SE
K9353043M Dental Electronic Anesthesia (Dea) System 8670LWM · Traditional 3M Company03/16/1994SE
K9350853M Dental Electrononic Anesthesia (DEA0 System 8670 Additional ApplicationsLWM · Traditional 3M Company01/26/1994SE
K9350823M Dental Electronic Anesthesia (Dea) System 8670 ModificationLWM · Traditional 3M Company01/26/1994SE
K915717CedetaLWM · Traditional D-W Intl.11/23/1992SE
K9201193M Dental Electronic Anesthesia SystemLWM · Traditional 3M Company05/22/1992SE
K910625UltracalmLWM · Traditional Sion Technology, Inc.05/15/1992SE

More from Sion Technology, Inc.

510(k)DeviceDecision
K884586Comfortron Dental Anesthesia ApparatusLWM · Traditional 04/14/1989SE
K871227Les Rad FilterITY · Traditional 06/29/1987SE

Questions and answers

When was Comfortron II (TENS) cleared by the FDA?

Comfortron II (TENS) (K902948) received a 510(k) decision of Substantially Equivalent on December 17, 1990, 165 days after the submission was received.

What is the product code of K902948?

The FDA product code is LWM – Device, Electrical Dental Anesthesia, a Unclassified device.