FDA 510(k)

WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A

Numéro K : K162663 · 2017-01-17

Date de décision2017-01-17

Code produitGZJ

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A is the device name listed in this FDA 510(k) record. The listed applicant is Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2017-01-17 under 510(k) number K162663. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A?

WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A is a medical device that received FDA 510(k) clearance on 2017-01-17. The listed applicant is Well-Life Healthcare Limited. The 510(k) number is K162663.

When did WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A receive FDA 510(k) clearance?

WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A received FDA 510(k) clearance on 2017-01-17, under 510(k) number K162663.

Who is the listed applicant for WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A?

The FDA 510(k) record lists Well-Life Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A?

The FDA product code for WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A is GZJ.

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Autres dossiers indiquant Well-Life Healthcare Limited en tant que demandeur

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Dispositifs connexes (Code : GZJ)

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Source officielle

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