Pain Buddy

FDA 510(k) K102051 · Biomedical Life Systems, Inc.

Substantially Equivalent

510(k) numberK102051

Submission

Device name
Pain Buddy
Applicant
Biomedical Life Systems, Inc.
Vista, CA, US
Received
July 21, 2010
Decision date
July 29, 2011
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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More from Sigma Biomedical

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K172971BMLS16-1NUH · Traditional 07/08/2018SE
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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 Pain Buddy cleared by the FDA?

Pain Buddy (K102051) received a 510(k) decision of Substantially Equivalent on July 29, 2011, 373 days after the submission was received.

What is the product code of K102051?

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