sam X1

Primary DI
00857599005202
Brand
sam X1
Company
ZETROZ SYSTEMS, LLC
Model
SA551
Catalog number
SA551
Device description
The sustained acoustic medicine, (sam® X1) long-duration ultrasound device is used in the treatment of musculoskeletal injuries and pain relief. sam® X1 is the first wire-free option to deliver continuous wave, high-frequency sustained acoustic medicine (3MHz) into deep tissue resulting in improved circulation and nutrient transfer into the injured soft-tissue for multiple hours each day. This sam® mechanism of action improves and accelerates soft tissue healing for tendinopathies, meniscus injuries, osteoarthritis, joint injuries (knee, shoulder, elbow, wrist) and tissue compromised by repetitive and/or overuse injuries. For pain management secondary to injury, sam® X1 provides localized, non-systemic pain management and is an appropriate treatment alternative for prescribers seeking to avoid the systemic effects of NSAIDs and opiates. sam® X1 is FDA cleared and indicated for prescription home-use, and easily accommodates self-administered treatment by applying the treatment applicator with a hypoallergenic single use pre-filled coupling patch over the soft-tissue injury and activating the battery-operated power controller for autonomous therapeutic delivery.
Published
2022-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211513000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211513000sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC2021-08-18PFW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857599005202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857599005202008575990052028575990052020857599005202

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
080128497
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857599005271sam 2.0 OA multi-hour continuous ultrasound device for home useSAM 2.0 OA24OA242026-04-07
00857599005257sam(R) Advanced Gel Capture PatchUB-14UB-14-15W2024-10-10
00857599005172sam(R) Advanced Gel Capture PatchUB-14UB14-15T2024-10-10
00857599005097sam coupling patchUB-122016-10-10
00857599005165sam(R) Advanced Gel Capture PatchUB-14UB-14-15W2024-10-10
00857599005196sam 2.0 Long Duration Ultrasound Device for Home UseSA2712021-11-30
00857599005073samsam-122016-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857599005271sam 2.0 OA multi-hour continuous ultrasound device for home useZETROZ SYSTEMS, LLCPFW2026-04-07
00850033615227Echo Ultrasound Device (PRC) THERMOTEK, INC.PFW2026-02-23
00850033615258Echo Ultrasound Device (PRC)THERMOTEK, INC.PFW2026-02-23
00850033615289Echo Ultrasound Device (USA)THERMOTEK, INC.PFW2026-02-23
00850033615340Echo Ultrasound Device (USA)THERMOTEK, INC.PFW2026-02-23
00850033615371Echo BOX, DRESSING & GEL POD PACK, USND, PRCTHERMOTEK, INC.PFW2026-02-23
00850033615388Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXESTHERMOTEK, INC.PFW2026-02-23
00850033615425Echo Ultra Sound Gel Pods, CartonTHERMOTEK, INC.PFW2026-02-23
00850033615487Echo Ultra Sound Gel Pod, SingleTHERMOTEK, INC.PFW2026-02-23
00850033615500Echo APPLICATOR, SINGLE, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615517Echo POWER SUPPLY, CORD, SINGLE, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615531Echo BELT CLIP, DEVICE PRTCTR, SNGL,USNDTHERMOTEK, INC.PFW2026-02-23
00850033615555Echo ARM STRAP, DEVICE PRTCTR, SNG, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615562Echo GEL, TUBE, SINGLE, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615586echoRx, MANUAL, USER, SINGLE, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615593echoRx, GUIDE,QUICK START,SNGL,USNDTHERMOTEK, INC.PFW2026-02-23
00850033615623Echo CTN, DRESSINGS, USND, USA, QTY 4 BOXESTHERMOTEK, INC.PFW2026-02-23
00850033615630Echo BOX, DRESSING & GEL POD PACK, USND, USATHERMOTEK, INC.PFW2026-02-23
00810113682778ManaMed Transducer Holder PatchManamed, Inc.PFW2025-09-11
00810113682754ManaMed Transducer Fixation StrapManamed, Inc.PFW2025-09-11
00810113682761ManaMed Transducer Fixation StrapManamed, Inc.PFW2025-09-11
00857599005257sam(R) Advanced Gel Capture PatchZETROZ SYSTEMS, LLCPFW2024-10-10
00857599005172sam(R) Advanced Gel Capture PatchZETROZ SYSTEMS, LLCPFW2024-10-10
00857599005165sam(R) Advanced Gel Capture PatchZETROZ SYSTEMS, LLCPFW2024-10-10
07290103422011PainShield PatchNANOVIBRONIX INC.PFW2023-07-24
07290103421144PainShield 3.0 ActuatorNANOVIBRONIX INC.PFW2023-07-16
07290103421328PainShield Plus Actuator NANOVIBRONIX INC.PFW2023-07-16
07290103422028PainShield 3.0 Driver NANOVIBRONIX INC.PFW2023-07-16
07290103422035PainShield Plus 3.0 Driver NANOVIBRONIX INC.PFW2023-07-16
00810113682396ManaSport+Manamed, Inc.PFW2022-06-20