BMLS16-1

FDA 510(k) K172971 · Biomedical Life Systems, Inc.

Substantially Equivalent

510(k) numberK172971

Submission

Device name
BMLS16-1
Applicant
Biomedical Life Systems, Inc.
Vista, CA, US
Received
September 26, 2017
Decision date
July 8, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special Everyway Medical Instruments Co.,Ltd11/21/2025SE
K243131Triathlon ProNUH · Traditional Sigma Biomedical11/07/2025SE

More from Sigma Biomedical

510(k)DeviceDecision
K102051Pain BuddyNUH · Traditional 07/29/2011SE
K061476Electro-Nerve Stimulator TENS, Model BMLS06-1GZJ · Traditional 07/26/2006SE
K042711Model BMLS03-7GZJ · Traditional 03/14/2005SE
K041388Combination Powered Electrical Muscle Stimulator and Interferential Stimulator, Model…GZJ · Traditional 11/23/2004SE
K040007Interferential Stimulator, Model BMLS02-6LIH · Traditional 07/07/2004SE
K033174BMLS03-3IPF · Traditional 06/30/2004SE
K040824Interferential Stimulator, Model BMLS03-6LIH · Traditional 04/29/2004SE
K040306High Voltage Pulsed Stimulator, Model BMLS02-7IPF · Traditional 03/23/2004SE
K033455Electro-Nerve Stimulator TENS, Model BMLS03-5GZJ · Traditional 01/15/2004SE
K031427Electro Neuromuscular Stimulator, Model BMLS03-1IPF · Traditional 08/19/2003SE

Questions and answers

When was BMLS16-1 cleared by the FDA?

BMLS16-1 (K172971) received a 510(k) decision of Substantially Equivalent on July 8, 2018, 285 days after the submission was received.

What is the product code of K172971?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.