Skip to content

CRYOPress

by Grimm Scientific Industries, Inc.

CRYOPress is a pneumatic massager (FDA Class II; FDA product code IRP, Massager, Powered Inflatable Tube) made by Grimm Scientific Industries, Inc., cleared under FDA 510(k) K951769 on 16 Oct 1995 and listed in FDA GUDID since 14 Aug 2016 (UDI-DI 00861047000312), 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) K951769

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 Number00861047000312 UDI-DI Date14 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK951769 Date16 Oct 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K951769 decided 16 Oct 1995 Active
  • FDA GUDID UDI-DI 00861047000312 listed 14 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K951769
  2. Listed FDA GUDID 00861047000312

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Pneumatic massager
Model / reference
CRYOPress
Primary DI / UDI-DI
00861047000312
510(k) Number
FDA product code
IRP
GMDN term
Pneumatic massager
Device class
Class II
Regulation number
890.5650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pneumatic massager

Similar devices

Other devices filed under FDA product code IRP (Massager, Powered Inflatable Tube).

Other devices from Grimm Scientific Industries, Inc.

  • CRYOTherm

    Class II

  • PARATherm

    Class II

  • Para Therm Bath

    Class II

  • Cryopress

    Class II

See all devices from Grimm Scientific Industries, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Serial number
Other properties (12, all answered No)