FDA.reportPublic FDA data

HF54, Horizon

Primary DI
00860001452532
Brand
HF54, Horizon
Company
HILL LABORATORIES CO.
Model
HF54, Horizon
Published
2020-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep HeatPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062256000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062256000HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEMHill Laboratories Co.2007-02-26IMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001452532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001452532008600014525328600014525320860001452532

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy ultrasound systemAn assembly of devices designed to produce and deliver ultrasonic waves that penetrate tissues and produce both thermal and nonthermal (e.g., mechanical and cavitation) effects to treat pain (e.g., muscle, tendon, joint) and as an aid in the healing of soft-tissue injuries (e.g., ulcerations, bursitis). It typically consists of a radio-frequency (RF) generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy to the applicator, and an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tissues through the skin.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002326585
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850058158051HA90PHA90P2023-10-24
00850058158075HA90PTHA90PT2023-10-24
00850058158105HI-LOHI-LO2023-10-24
00850058158136Rath Mechanical Extension TableRath Mechanical2023-10-24
00860001452556Spinalight, IncSpinalight C-10002023-10-24
00850058158037HA90LBC CounterstrainHA90LBC Counterstrain2023-10-23
00860001452587HA90CHA90C2023-10-23
00860001452594HA90HA902023-10-23
00860011173601HA90EHA90E2023-10-23
00850058158143The SAVE ProgramSAVE Motion Chair2024-03-11
00860011173649Advanced Chiropractic Equipment LLCHA90RD2023-10-23
00850058158006HA90RHA90R2023-10-24
00850058158068HA90PHHA90PH2023-10-24
00850058158082HA90VHA90V2023-10-24
00850058158099HA90WHA90W2023-10-24
00850058158112Massage TableMassage Table2023-10-24
00850058158129PT Tilt TablePT Tilt Table2023-10-24
00850058158013HA90DHA90D2023-10-23
00850058158020HA90LBHA90LB2023-10-23
00850058158044HA90MHA90M2023-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800016213034PLASONICHironic Co., ltd.IMI2026-03-18
00850033615227Echo Ultrasound Device (PRC) THERMOTEK, INC.IMI2026-02-23
00850033615258Echo Ultrasound Device (PRC)THERMOTEK, INC.IMI2026-02-23
00850033615289Echo Ultrasound Device (USA)THERMOTEK, INC.IMI2026-02-23
00850033615340Echo Ultrasound Device (USA)THERMOTEK, INC.IMI2026-02-23
00850033615371Echo BOX, DRESSING & GEL POD PACK, USND, PRCTHERMOTEK, INC.IMI2026-02-23
00850033615388Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXESTHERMOTEK, INC.IMI2026-02-23
00850033615425Echo Ultra Sound Gel Pods, CartonTHERMOTEK, INC.IMI2026-02-23
00850033615487Echo Ultra Sound Gel Pod, SingleTHERMOTEK, INC.IMI2026-02-23
00850033615500Echo APPLICATOR, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615517Echo POWER SUPPLY, CORD, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615531Echo BELT CLIP, DEVICE PRTCTR, SNGL,USNDTHERMOTEK, INC.IMI2026-02-23
00850033615555Echo ARM STRAP, DEVICE PRTCTR, SNG, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615562Echo GEL, TUBE, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615586echoRx, MANUAL, USER, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615593echoRx, GUIDE,QUICK START,SNGL,USNDTHERMOTEK, INC.IMI2026-02-23
00850033615623Echo CTN, DRESSINGS, USND, USA, QTY 4 BOXESTHERMOTEK, INC.IMI2026-02-23
00850033615630Echo BOX, DRESSING & GEL POD PACK, USND, USATHERMOTEK, INC.IMI2026-02-23
00810113682778ManaMed Transducer Holder PatchManamed, Inc.IMI2025-09-11
00810113682754ManaMed Transducer Fixation StrapManamed, Inc.IMI2025-09-11
00810113682761ManaMed Transducer Fixation StrapManamed, Inc.IMI2025-09-11
00850998008546ManaMed Transducer Holder PatchManamed, Inc.IMI2025-09-11
08720618311108Sonopuls 190Enraf-Nonius B.V.IMI2025-02-11
08720618311221Sonopuls 190Enraf-Nonius B.V.IMI2025-02-11
00850030915191RichmarSouth Dakota Partners Inc.IMI2023-08-02
00850030915214RichmarSouth Dakota Partners Inc.IMI2023-08-02
00850030915221RichmarSouth Dakota Partners Inc.IMI2023-08-02
07290110122317Accent Prime System 120V For Inc.ALMA LASERS LTD.IMI2022-11-22
07290110122324Accent Prime UltraSpeed Applicator for Inc.ALMA LASERS LTD.IMI2022-11-22
07290110122331Accent Prime MiniSpeed Applicator for Inc.ALMA LASERS LTD.IMI2022-11-22