DEVICE: N/A (00092237616802)

Device Identifier (DI) Information

N/A
DU1025
In Commercial Distribution

Roscoe Medical
00092237616802
GS1

1
022542271 *Terms of Use
US 1000 3rd - Portable
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Physical therapy ultrasound system An 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.
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FDA Product Code

[?]
Product Code Product Code Name
IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092627 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

d1e1a309-732e-47cd-ba9b-52568ce87ffc
July 06, 2018
3
October 13, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
80092237616808 20 00092237616802 In Commercial Distribution CA
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
440-572-1962
CustomerService@compasshealthbrands.com
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