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Tru-Tech 310 Ultrasound Therapy Unit #310

by Tru-Trac Therapy Products, Inc. 510(k)

Active United States

510(k) K881211

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881211 Date11 May 1988ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IMI
Device Class
Class II
Regulation
21 CFR Part 890.5300
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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