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Passive Heat Pads

by Biotone International, Inc. 510(k)

Active United States

510(k) K821692

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821692 Date13 Jul 1982ClearedStatusActive

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  • Withdrawn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
IRT
Device Class
Class II
Regulation
21 CFR Part 890.5740
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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