Facility

ONDAMED INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011088301
Establishment type	Manufacture Medical Device
Location	5 FAIRLAWN DR STE 200 WASHINGTONVILLE, NY, US 10992
Registration status	Active · expires 2026
Parent company	Ondamed Inc. (owner-operator 9052444)
Brand names	ONDAMED

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Device, Biofeedback
Product code HCC (opens in a new tab) · Class II · Neurology · 21 CFR 882.5050

Recalls & enforcement

Class IITerminated2017-07-07
The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has notified customers that an upgrade for the device is now available, which includes the addition of …

FDA inspections (3)

NAI2026-07-15
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2018-09-28
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2016-08-15
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Ondamed Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ONDAMED INC. (FEI 3011088301) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011088301-ondamed-inc/

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