← FDA Medical Device Classifications

Bath, Hydro-Massage

ILJ · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5100

Classification

FDA Product Code

ILJ

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 890.5100

Review panel

PM

Medical specialty

Physical Medicine

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

73

Registered establishments

7

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown