Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
K-Number: K181207 · 2018-06-06
Device Summary
Frequently Asked Questions
What is the Balego TENS Digital Edition with Accessories for Pain Relief (OTC)?
Balego TENS Digital Edition with Accessories for Pain Relief (OTC) is a medical device that received FDA 510(k) clearance on 2018-06-06. The listed applicant is Everyway Medical Instruments Co., Ldt.. The 510(k) number is K181207.
When did Balego TENS Digital Edition with Accessories for Pain Relief (OTC) receive FDA 510(k) clearance?
Balego TENS Digital Edition with Accessories for Pain Relief (OTC) received FDA 510(k) clearance on 2018-06-06, under 510(k) number K181207.
Who is the listed applicant for Balego TENS Digital Edition with Accessories for Pain Relief (OTC)?
The FDA 510(k) record lists Everyway Medical Instruments Co., Ldt. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Balego TENS Digital Edition with Accessories for Pain Relief (OTC)?
The FDA product code for Balego TENS Digital Edition with Accessories for Pain Relief (OTC) is NUH.
Other records listing Everyway Medical Instruments Co., Ldt. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: NUH)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.