FDA.report

CHATTANOOGA

Primary DI
00190446673170
Brand
CHATTANOOGA
Company
DJO, LLC
Model
2176KIT
Device description
INTELECT RPW 2 120V, USA KIT
Published
2022-02-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ISAMassager, therapeutic, electric

Product Code Classifications

CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190446673170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446673170001904466731701904466731700190446673170

GMDN Terms

TermDefinition
Pneumatic orthopaedic extracorporeal shock wave therapy systemAn assembly of devices designed to provide pneumatic orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. It typically consists of a control unit that produces pneumatically-generated shock waves at selected impulse frequencies, and a hand-held surface applicator used to apply the energy to the site of pain. It is commonly used to treat disorders such as tendinopathies (e.g., rotator cuff, patellar, Achilles), soft tissue pain near bones, plantar fasciitis (heel pain), epicondylopathy (tennis elbow), shin splints, and muscle-related pain syndromes.

Sterilization Methods

Method

Regulatory Flags

DUNS number
081840873
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00190446968344DJO SURGICALS-2019632026-03-16
00190446953685DJO SURGICALS-2019592026-02-17
00190446953708DJO SURGICALS-2019582026-02-17
00888912408691DJO SURGICAL800-05-0242023-01-18
00190446940920DJO SURGICALS-2019462025-11-18
00190446660453PROCARE155-81-974272025-07-23
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00190446662686PROCARE155-BH-1942025-07-23
00190446660354PROCARE155-79-843002025-07-14
00190446660583PROCARE155-79-84100C2025-07-14
00190446662785PROCARE155-BH827102025-07-14
00190446662891PROCARE155-81-874802025-07-14
00190446662907PROCARE155-81-874902025-07-14
00190446662914PROCARE155-81-874602025-07-14
00190446662921PROCARE155-81-874702025-07-14
00190446662792PROCARE155-81-873022025-07-11
00190446662808PROCARE155-81-873032025-07-11
00190446662815PROCARE155-81-873052025-07-11
00190446662822PROCARE155-81-873072025-07-11
00190446662839PROCARE155-81-873082025-07-11

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