AVACEN, INC.

Matched from indexed company URL: AVACEN INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3009668937	3009668937	AVACEN, INC.	1	N	2026-01-01	6451 El Camino Real Ste C Carlsbad CA US 92009

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00862800000303	AVACEN - The AVACEN HOME consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN HOME for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.	888-428-2236	support@avacen.com
00862800000334	AVACEN - 25-pack Mitts	888-428-2236	support@avacen.com

avacen.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
142374	1068138980	K133981	AVACEN 100	IRT	2014-08-15
142374	2021697731
142374	1567399722

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
IRT	2	2014-08-15

PMN#

AVACEN 100
2014-08-15
AVACEN INC.

GUDID#

AVACEN - The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. TheAVACEN HOME XL is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches andpains. The user places their hand into the AVACEN HOME XL for approximately 10 to 60 minutes per treatment session. A vacuum pumpcreates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
2023-03-10
AVACEN - The POP-ON/POP-OFF cuff is for replacement part on Gen 3 AVACEN products (HOME XL and PRO+).
AVACEN MEDICAL, INC
2023-03-10
AVACEN - The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. TheAVACEN HOME XL is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches andpains. The user places their hand into the AVACEN HOME XL for approximately 10 to 60 minutes per treatment session. A vacuum pumpcreates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
2023-03-10
AVACEN - The AVACEN HOME+ consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. TheAVACEN HOME+ is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches andpains. The user places their hand into the AVACEN HOME+ for approximately 10 to 30 minutes per treatment session. A vacuum pumpcreates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
2023-03-10
AVACEN - The AVACEN HOME consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN HOME for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
2017-05-03
AVACEN - The AVACEN HOME+ consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME+ is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN HOME+ for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
2019-12-31
AVACEN - The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. TheAVACEN HOME XL is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches andpains. The user places their hand into the AVACEN HOME XL for approximately 10 to 60 minutes per treatment session. A vacuum pumpcreates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
2022-10-28
AVACEN - 25-pack Mitts
AVACEN MEDICAL, INC
2017-07-19
AVACEN - 100-pack Mitts
AVACEN MEDICAL, INC
2017-05-03
AVACEN - Vacuum Chamber Insert (VCI)
AVACEN MEDICAL, INC
2017-05-03