DEVICE: N/A (00023601220004)

Device Identifier (DI) Information

N/A
ACRL-2000
Not in Commercial Distribution

Carex Health Brands
00023601220004
GS1
May 30, 2018
1
082522269 *Terms of Use
AccuRelief Single Channel TENS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
Yes
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 electrical stimulation system, battery-powered An assembly of battery-powered devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical stimulation of calf muscles to prevent venous thrombosis, and/or to maintain or increase range of motion.
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FDA Product Code

[?]
Product Code Product Code Name
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

b876bbec-ecb4-4286-ab2e-2f922891eba4
July 10, 2018
5
October 12, 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
30023601220005 6 00023601220004 2018-05-30 Not in Commercial Distribution PK
50023601220078 4 30023601220005 2018-05-30 Not in Commercial Distribution
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Secondary DI

[?]
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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