Cryotherm
by Grimm Scientific Industries, Inc.
510(k) K864721
Cryotherm is a medical device (FDA Class II; FDA product code ILJ, Bath, Hydro-Massage) made by Grimm Scientific Industries, Inc., cleared under FDA 510(k) K864721 on 4 Feb 1987, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864721 | Date4 Feb 1987 | StatusActive |
Official records
- FDA 510(k) database K864721
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ILJ
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5100
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code ILJ (Bath, Hydro-Massage).
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- HYDROTONE I by Hydrotonics Therapy Corp.
- VICHY SHOWER by Bouvier Hydro, Inc.
- WHIRLPOOL BATH MODEL 2270 by Dazey Products Co.
- VANNA BATHING SYSTEM by VANCARE INC
- PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM by Penner Manufacturing, Inc.
- SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM by Intl. Health Technology, Inc.
- BIOTHERM by Trileen, Inc.