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ThermoTek WRAP, KNEE, ROM BRACE, XL, 13" 0P9BRMLX13-XL

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 Number00850033615197 UDI-DI Date21 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  • Withdrawn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
ThermoTek WRAP, KNEE, ROM BRACE, XL, 13"
Generic Name
Circulating-fluid localized thermal therapy system pack, single-use
Model / Ref / Catalog
0P9BRMLX13-XL
Primary DI / UDI-DI
00850033615197
510(k) Number
FDA Product Code
ILO, JOW, ITQ
GMDN Term
Circulating-fluid localized thermal therapy system pack, single-use
Device Class
Class II
Regulation Number
890.5720, 870.5800, 890.3475
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K061866)

Show all (12)

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Properties

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

Other properties (10)

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