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PARATherm

by Grimm Scientific Industries, Inc.

PARATherm is a physical therapy paraffin wax bath (FDA Class II; FDA product code IMC, Bath, Paraffin) made by Grimm Scientific Industries, Inc., cleared under FDA 510(k) K842423 on 28 Jun 1984 and listed in FDA GUDID since 14 Aug 2016 (UDI-DI 00861047000329), active as of 21 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 21 Oct 2026

Documents

510(k) K842423

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00861047000329 UDI-DI Date14 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK842423 Date28 Jun 1984DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K842423 decided 28 Jun 1984 Active
  • FDA GUDID UDI-DI 00861047000329 listed 14 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K842423
  2. Listed FDA GUDID 00861047000329

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Physical therapy paraffin wax bath
Model / reference
PARATherm
Primary DI / UDI-DI
00861047000329
510(k) Number
FDA product code
IMC
GMDN term
Physical therapy paraffin wax bath
Device class
Class II
Regulation number
890.5110
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IMC (Bath, Paraffin).

Other devices from Grimm Scientific Industries, Inc.

  • CRYOTherm

    Class II
  • CRYOPress

    Class II
  • Para Therm Bath

    Class II
  • Cryotherm

    Class II

See all devices from Grimm Scientific Industries, Inc. →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)