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Echo BOX, DRESSING & GEL POD PACK, USND, USA 0V52XX1012JK01

by Thermotek, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850033615630 UDI-DI Date23 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Echo BOX, DRESSING & GEL POD PACK, USND, USA
Generic Name
Physical therapy ultrasound system
Model / Ref / Catalog
0V52XX1012JK01
Primary DI / UDI-DI
00850033615630
510(k) Number
FDA Product Code
IMI, PFW
GMDN Term
Physical therapy ultrasound system
Device Class
Class II
Regulation Number
890.5300
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K240788)

Show all (12)

Other devices from Thermotek, Inc.

See all devices from Thermotek, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No