FDA.reportPublic FDA data

ACTitouch

Primary DI
00816305023053
Brand
ACTitouch
Company
Tactile Systems Technology, Inc.
Model
DS 500222-500-00
Published
2017-10-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071763000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071763000AMADEUS ADAPTIVE COMPRESSION THERAPYConvatec2008-03-07JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816305023053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816305023053008163050230538163050230530816305023053

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
146295980
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816305024890AffloVest6100XS2026-05-27
00816305024906AffloVest6200S2026-05-27
00816305024913AffloVest6300M2026-05-27
00816305024920AffloVest6400L2026-05-27
00816305024937AffloVest6500XL2026-05-27
00816305025101AffloVest704268-001704268-0012026-05-27
00816305025248AffloVestWR6100XS2026-05-27
00816305025255AffloVestWR6200S2026-05-27
00816305025262AffloVestWR6300M2026-05-27
00816305025279AffloVestWR6400L2026-05-27
00816305025286AffloVestWR6500XL2026-05-27
00816305025088FlexiTouch Plus704705-001N/A2025-08-11
00816305025095Nimbl703439-001N/A2025-08-11
00816305025064FlexiTouch Plus702610-0012025-07-17
00816305025071NimblDS PL-HL-00-LR2025-07-17
00816305023596Airwear Air Compression WrapAW-SM-01-BK2019-10-18
00816305023602Airwear Air Compression WrapAW-MD-01-BK2019-10-18
00816305023619Airwear Air Compression WrapAW-LG-01-BK2019-10-18
00816305023626Airwear Air Compression WrapAW-XL-01-BK2019-10-18
00816305023633Airwear Air Compression WrapAW-SO-01-WH2019-10-18

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00850078826299BioTAB LLCBiotab LLCJOW2026-10-26
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50885380194625KendallCardinal Health 200, LLCJOW2026-07-31
50885380194632KendallCardinal Health 200, LLCJOW2026-07-31
50885380194649KendallCardinal Health 200, LLCJOW2026-07-31
50885380194656KendallCardinal Health 200, LLCJOW2026-07-31
50885380194663KendallCardinal Health 200, LLCJOW2026-07-31
50885380194670KendallCardinal Health 200, LLCJOW2026-07-31