Facility

MEDDEV CORP.

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)	2921577
Establishment type	Manufacture Medical Device
Location	730 NORTH PASTORIA AVE. SUNNYVALE, CA, US 94085
Registration status	Active · expires 2026
Parent company	MEDDEV CORP. (owner-operator 2921577)
Brand names	THE HAND HELPER

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Exerciser, Non-Measuring
Product code ION (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.5370

Recalls & enforcement

Class IIOngoing2024-07-12
Due to mislabeling of products

FDA inspections (3)

VAI2025-03-12
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2022-02-28
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-01-03
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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 MEDDEV CORP.

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. “MEDDEV CORP. (FEI 2921577) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2921577-meddev-corp/

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