Facility

OMM IMPORTS, INC. D/B/A ZERO GRAVITY

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

Key facts

1recalls · worst Class II

1inspections · 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)	3012327767
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	940 Lincoln Rd Miami Beach, FL, US 33139
Registration status	Active · expires 2026
Parent company	Omm Imports, Inc. d/b/a Zero Gravity (owner-operator 10051405)
Brand names	ONE by ELEVARE; Perfectio X; Relaxatio; RED; Spirulux Model S; PRO MED BY JOUVALLE; MODEL S+ BY SPIRULUX

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Lamp, Infrared, Therapeutic Heating
Product code ILY (opens in a new tab) · Class II · Physical Medicine · 21 CFR 890.5500

Recalls & enforcement

Class IIOngoing2022-09-01
The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm failed to provide safety information, reproductions and locations of the labels, and a warning statement in the user manual.

FDA inspections (1)

NAI2022-09-09
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · 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 Omm Imports, Inc. d/b/a Zero Gravity

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. “OMM IMPORTS, INC. D/B/A ZERO GRAVITY (FEI 3012327767) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012327767-omm-imports-inc-d-b-a-zero-gravity/

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