accufit

Primary DI
00816864021682
Brand
accufit
Company
METTLER ELECTRONICS CORP.
Model
accufit
Device description
Indications for Use:- Relaxation of muscle spasms- Prevention or retardation of disuse atrophy- Increase local blood circulation- Muscle re-education- Maintaining or increasing range of motion- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis- Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.- Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233926000accufitMettler Electronics Corporation2024-03-21IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816864021682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816864021682008168640216828168640216820816864021682

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Regulatory Flags#

DUNS number
008513913
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816864020210Sonicator Plus 920ME 920ME 9202016-09-15
00816864020227Sonicator Plus 930, 2 channelME 930ME 9302016-09-15
00816864020234Sonicator Plus 940, 4 channelME 940ME 9402016-09-15
00816864020241Sonicator Plus 992, 2 channelME 992ME 9922016-09-15
00816864020258Sonicator Plus 994, 4 channelME 994ME 9942016-09-15
00816864020609Ultrasound Applicator 7410741074102016-09-15
00816864020616Ultrasound Applicator 7413741374132016-09-15
00816864020623Ultrasound Applicator 7431743174312016-09-15
00816864020630Applicator 7513751375132016-09-15
00816864020647Applicator 9201920192012016-09-15
00816864020654Applicator 9202920292022016-09-15
00816864020661Applicator 9401940194012016-09-15
00816864020678Applicator 9402940294022016-09-15
00816864020708Applicator 7001700170012016-09-15
00816864020715Applicator 7005700570052016-09-15
00816864020722Applicator 7107710771072016-09-15
00816864020739Applicator 7305730573052016-09-15
00816864020746Applicator 7310731073102016-09-15
00816864020753Applicator 7331733173312016-09-15
00816864020760Applicator 7335733573352016-09-15

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Primary DI, Brand, Company table
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