FDA.reportPublic FDA data

G5®

Primary DI
00746980000974
Brand
G5®
Company
GENERAL PHYSIOTHERAPY INC
Model
GK 24 NB
Catalog number
GK 24 NB
Device description
"The G5 GK-3 is a quiet & powerful Massage Machine designed for rugged use in the office, clinic, school, gym, training room or home. Each GK-3 has a 47 3/4"" long, light-weight, smooth drive cable attached to a durable applicator head, to provide greater versatility and ease of use. The GK-3 incorporates a dial-controlled, variable-speed output, with speeds from 20 - 60 cycles per second.Unit Advantages: Economical Stand Mount or Portable Configurations Basic Control Panel with CPS Indicator (Low, Medium, High) Comes complete with choice of applicator package"
Published
2017-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYIPercussor, Powered-Electric
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYIPercussor, Powered-ElectricAnesthesiology2
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00746980000974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00746980000974007469800009747469800009740746980000974

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal chest percussorA hand-held battery-powered device (a percussor) intended to be operated by a healthcare professional to provide external vibrations to the chest wall of a neonate to help loosen bronchial mucus for expectoration through suctioning. It is small enough in physical dimension and weight to be operated inside an infant incubator and has a percussion head suitable for the thorax of a neonate. It is used to help loosen secretion build-up in the lungs of neonates who cannot perform the natural cough mechanism.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight3Pound
Weight38Pound

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-237-1832DNICKELSON@G5.COM

Regulatory Flags#

DUNS number
098639974
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00746980002022G5®GK120BGK120B2017-05-12
00746980002268G5®ME 610 24 VME 610 24 V2017-06-12
00746980002640G5®VM 240 WDVM 240 WD2017-07-21
00746980002718G5®ME 610 240 VME 610 240 V2017-07-21
00746980001582G5®ALC 120 G5ALC 120 G52017-04-26
00746980001650G5®ALC 240 G5ALC 240 G52017-05-01
00746980001728G5®CL120WCL120W2017-05-01
00746980001964G5®GK 240 BGK240B2017-05-11
00746980001278G5®TS240WBJSTS240WBJS2017-04-26
00746980001100G5®VM 24 WDVM 24 WD2017-04-25
00746980000806G5®GK 24 BGK 24 B2017-03-01
00746980001346G5®GK 240 NBGK 240 B2017-04-26
00746980000592G5®CEL 24 WCEL 24 W2017-03-01
00746980000660G5®TRS 24 WTRS 24 W2017-03-01
00746980001414G5®TS240WTS240W2017-04-26
00746980001896G5®CL240WCL240W2017-05-01
00746980002336G5®TS120WTS120W2017-06-12
00007469820231G5®VIBRACARE ZX1VIBRACARE ZX12023-10-25
00746980002190G5®ME 600ME 6002017-06-12
00746980000356G5FF24BFF24B2020-09-28

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Primary DI, Brand, Company table
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088095244976843H Smart Massage Bed3H, Co., LtdISA2026-07-29
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088095244977213H Smart Massage Bed3H, Co., LtdISA2026-07-29
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088095244977453H Smart Massage Bed3H, Co., LtdISA2026-07-29
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088095244976773H Smart Massage Bed3H, Co., LtdISA2026-07-28
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00850071298017Smart-RSTHyperion Medical Technologies, Inc.ISA2026-06-02
00841470100841PercussorPULMODYNE INCBYI2026-05-29
00841470100858PercussorPULMODYNE INCBYI2026-05-29
00816305024890AffloVestTactile Systems Technology, Inc.BYI2026-05-27
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00816305024920AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024937AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025101AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025248AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025255AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025262AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025279AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025286AffloVestTactile Systems Technology, Inc.BYI2026-05-27
16973368290059MedisanaZhangzhou Easepal Medical Science And Technology Co., Ltd.ISA2026-04-30