510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K883812Substantially Equivalent

Hp-1 (Healthpax)

Healthdirections, Inc., Morrisville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883812 is the FDA 510(k) clearance record for HP-1 (HEALTHPAX), a class II device, cleared for Healthdirections, Inc. on under FDA product code QJQ (Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety). FDA's definition for product code QJQ reads: "To provide electrical current to the head to treat insomnia and/or anxiety". FDA records list one 510(k) clearance for Healthdirections, Inc. As of , FDA records show one recall naming K883812.

Clearance record

Decision date
Received
(81 days to decision)
Product code
QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Regulation
21 CFR 882.5800
Device class
Class II
Review panel
Neurology
Applicant
Healthdirections, Inc. Post Office Box 874, Morrisville PA
Third party review
No

Clearances, product code QJQ

Trailing 12 months
1 clearance under product code QJQ in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QJQ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260